Colorectal AdenomaTRACENCT03952611
Three Arm Rand Trial of HD Light vs Reveal® Cap vs Endocuff Cap for Detection of Colorectal Adenomas (TRACE)
A study testing Colonoscopy, distal Cap and Endocuff in people with Colorectal Adenoma, run by Midwest Biomedical Research at 1 site in United States.
Trial summary
Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas Hypothesis… Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- Colonoscopy, distal Cap and Endocuff
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,203 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Referral for screening or surveillance colonoscopy
- Ability to provide informed consent
Who cannot join
- Prior history of colon cancer
- History of inflammatory bowel disease
- Prior surgical resection of any part of the colon
- Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
- History of polyposis syndrome or HNPCC
- Inability to give informed consent
- Family history of colon cancer in a first degree relative < 60 years or two first degree relatives with colorectal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas City VA Hospital
Kansas City, Missouri, 64128
About this study
Official title: Three Arm Prospective Randomized Controlled Trial of HD White-light Colonoscopy vs HD White-light Colonoscopy With Reveal® Distal Attachment Cap Versus HD White-light Colonoscopy With Endocuff Vision for the Detection of Colorectal Adenomas
Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas
Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone
Read more
Design: Multicenter, Prospective, randomized controlled study
Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Read the detailed description
Hypothesis and specific aims of the Study
We hypothesize that the detection rate of patients with colorectal adenomas will be higher with HDWL colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopy alone.
Primary Aim:
To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Secondary Aims:
- To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
- To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Methodology:
This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. They will be randomized to one of 3 arms, i.e. HDWL colonoscopy HDWL colonoscopy with Reveal® cap or HDWL colonoscopy with Endocuff Vision.
Enrollment:
A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.
Length of the study:
The duration of the study is expected to be approximately 12 months. Enrollment of study patients will cease when approximately 1227 patients have been enrolled.
Inclusion criteria
- Referral for screening or surveillance colonoscopy
- Ability to provide informed consent
Exclusion criteria
- Prior history of colon cancer
- History of inflammatory bowel disease
- Prior surgical resection of any part of the colon
- Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
- History of polyposis syndrome or HNPCC
- Inability to give informed consent
- Family history of colon cancer in a first degree relative < 60 years or two first degree relatives with colorectal cancer
For three groups, moderate sedation will be administered in a standard fashion with intravenous midazolam, meperidine or fentanyl prior to undergoing colonoscopy.
The colonoscope (HDWL colonoscope or HDWL colonoscope with Reveal® cap or HDWL colonoscope with Endocuff Vision) will be inserted and cecum will be intubated. Photo documentation of the cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope.
The time from the point of insertion of the colonoscope into the rectum to the intubation of cecum will be recorded with a stop watch by a research coordinator and will be documented as the "insertion time".
The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the "withdrawal time". During withdrawal of the colonoscope the stop watch will be stopped whenever mucosa is being cleaned, fluid/solid debris is suctioned or a polyp is being removed to ensure that the withdrawal time is the actual representation of the mucosal inspection time. Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds, flexures and valves.
All polyps detected will be documented: size, location, and morphology (using the Paris classification - Appendix A). Photo documentation of the polyps will be performed.
Polyps will then be removed with a biopsy forceps or snare and sent for histopathological evaluation, each in a separate jar and labeled accordingly.
The bowel preparation will be evaluated and graded according to previously reported criteria using the Boston Bowel Preparation Scale (Appendix B). Complications including any mucosal trauma from the high definition colonoscope alone or with high definition colonoscope with Reveal® cap or Endocuff Vision, perforation or gastrointestinal bleeding (requiring intervention) will be recorded for three groups.
- Conditions
- Colorectal Adenoma
- Being tested
- Colonoscopy, distal Cap, Endocuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Using an instrument called colonoscope which is used to detect colonic polyps
distal CapDevice
Using an instrument called cap at end of colonoscope which is used to straighten colon folds
EndocuffDevice
Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
| Study group | Role | What they receive |
|---|---|---|
| High-Definition White-light Colonoscopy | Active comparator | Using an instrument called colonoscope which is used to detect colonic polyps Receives: Procedure: Colonoscopy |
| High-Definition White-light Colonoscopy With Reveal® | Active comparator | Using an instrument called cap at end of colonoscope which is used to straighten colon folds Receives: Procedure: Colonoscopy; Device: distal Cap |
| High-Definition White-light Colonoscopy With Endocuff Vision | Active comparator | Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds Receives: Procedure: Colonoscopy; Device: Endocuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Measured: Through the study (1 year)
Secondary outcomes (7)
Number of Adenomas per person
To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Measured: Through the study (1 year)
detection rates of advanced adenomas
To compare the detection rates for advanced adenomas of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Measured: Through the study (1 year)
detect rates of serrated polyps
To compare the detection rates for serrated polyps of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Measured: Through the study (1 year)
detect rates of right sided adenomas
To compare the detection rates of right sided adenomas of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Measured: Through the study (1 year)
to determine cecal intubation time
To compare the cecal intubation time of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Measured: Through the study (1 year)
to determine insertion and withdrawal time
To compare the insertion and withdrawal time of the procedure of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Measured: Through the study (1 year)
to determine complications
To compare the complications of procedure of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Measured: Through the study(1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start16 Mar 2018
- Primary completion20 Dec 2021
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three Arm Randomized Control Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Biomedical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prateek Sharma, MD, Principal investigator, Kansas City VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952611
- Sponsor's protocol ID
- RND#00978
- Acronym
- TRACE
- Status last verified
- Mar 2023
- First submitted
- 23 Oct 2017
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a multi- center study and we will receive de identified data from other centered via REDCAP
Publications
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
PubMed 22237781Winawer SJ, Zauber AG, Fletcher RH, Stillman JS, O'Brien MJ, Levin B, Smith RA, Lieberman DA, Burt RW, Levin TR, Bond JH, Brooks D, Byers T, Hyman N, Kirk L, Thorson A, Simmang C, Johnson D, Rex DK; US Multi-Society Task Force on Colorectal Cancer; American Cancer Society. Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society. Gastroenterology. 2006 May;130(6):1872-85. doi: 10.1053/j.gastro.2006.03.012.
PubMed 16697750Citarda F, Tomaselli G, Capocaccia R, Barcherini S, Crespi M; Italian Multicentre Study Group. Efficacy in standard clinical practice of colonoscopic polypectomy in reducing colorectal cancer incidence. Gut. 2001 Jun;48(6):812-5. doi: 10.1136/gut.48.6.812.
PubMed 11358901van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
PubMed 16454841Heresbach D, Barrioz T, Lapalus MG, Coumaros D, Bauret P, Potier P, Sautereau D, Boustiere C, Grimaud JC, Barthelemy C, See J, Serraj I, D'Halluin PN, Branger B, Ponchon T. Miss rate for colorectal neoplastic polyps: a prospective multicenter study of back-to-back video colonoscopies. Endoscopy. 2008 Apr;40(4):284-90. doi: 10.1055/s-2007-995618.
PubMed 18389446Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.
PubMed 25470133Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.
PubMed 21997547Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166.
PubMed 24921209Desai M, Rex DK, Bohm ME, Davitkov P, DeWitt JM, Fischer M, Faulx G, Heath R, Imler TD, James-Stevenson TN, Kahi CJ, Kessler WR, Kohli DR, McHenry L, Rai T, Rogers NA, Sagi SV, Sathyamurthy A, Vennalaganti P, Sundaram S, Patel H, Higbee A, Kennedy K, Lahr R, Stojadinovikj G, Campbell C, Dasari C, Parasa S, Faulx A, Sharma P. Impact of withdrawal time on adenoma detection rate: results from a prospective multicenter trial. Gastrointest Endosc. 2023 Mar;97(3):537-543.e2. doi: 10.1016/j.gie.2022.09.031. Epub 2022 Oct 10.
PubMed 36228700Desai M, Rex DK, Bohm ME, Davitkov P, DeWitt JM, Fischer M, Faulx G, Heath R, Imler TD, James-Stevenson TN, Kahi CJ, Kessler WR, Kohli DR, McHenry L, Rai T, Rogers NA, Sagi SV, Sathyamurthy A, Vennalaganti P, Sundaram S, Patel H, Higbee A, Kennedy K, Lahr R, Stojadinovikj G, Dasari C, Parasa S, Faulx A, Sharma P. High-Definition Colonoscopy Compared With Cuff- and Cap-Assisted Colonoscopy: Results From a Multicenter, Prospective, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2023-2031.e6. doi: 10.1016/j.cgh.2021.12.037. Epub 2021 Dec 31.
PubMed 34979245
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Arm Prospective Randomized Controlled Trial of HD White-light Colonoscopy vs HD White-light Colonoscopy With Reveal® Distal Attachment Cap Versus HD White-light Colonoscopy With Endocuff Vision for the Detection of Colorectal Adenomas
- ClinicalTrials.gov ID
- NCT03952611
- Acronym / sponsor ID
- TRACE / RND#00978
- Conditions
- Colorectal Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,203 participants (actual)
- Lead sponsor
- Midwest Biomedical ResearchUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas
Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone
Design: Multicenter, Prospective, randomized controlled study
Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Detailed description
Hypothesis and specific aims of the Study
We hypothesize that the detection rate of patients with colorectal adenomas will be higher with HDWL colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopy alone.
Primary Aim:
To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Secondary Aims:
- To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
- To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Methodology:
This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. They will be randomized to one of 3 arms, i.e. HDWL colonoscopy HDWL colonoscopy with Reveal® cap or HDWL colonoscopy with Endocuff Vision.
Enrollment:
A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.
Length of the study:
The duration of the study is expected to be approximately 12 months. Enrollment of study patients will cease when approximately 1227 patients have been enrolled.
Inclusion criteria
- Referral for screening or surveillance colonoscopy
- Ability to provide informed consent
Exclusion criteria
- Prior history of colon cancer
- History of inflammatory bowel disease
- Prior surgical resection of any part of the colon
- Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
- History of polyposis syndrome or HNPCC
- Inability to give informed consent
- Family history of colon cancer in a first degree relative < 60 years or two first degree relatives with colorectal cancer
For three groups, moderate sedation will be administered in a standard fashion with intravenous midazolam, meperidine or fentanyl prior to undergoing colonoscopy.
The colonoscope (HDWL colonoscope or HDWL colonoscope with Reveal® cap or HDWL colonoscope with Endocuff Vision) will be inserted and cecum will be intubated. Photo documentation of the cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope.
The time from the point of insertion of the colonoscope into the rectum to the intubation of cecum will be recorded with a stop watch by a research coordinator and will be documented as the "insertion time".
The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the "withdrawal time". During withdrawal of the colonoscope the stop watch will be stopped whenever mucosa is being cleaned, fluid/solid debris is suctioned or a polyp is being removed to ensure that the withdrawal time is the actual representation of the mucosal inspection time. Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds, flexures and valves.
All polyps detected will be documented: size, location, and morphology (using the Paris classification - Appendix A). Photo documentation of the polyps will be performed.
Polyps will then be removed with a biopsy forceps or snare and sent for histopathological evaluation, each in a separate jar and labeled accordingly.
The bowel preparation will be evaluated and graded according to previously reported criteria using the Boston Bowel Preparation Scale (Appendix B). Complications including any mucosal trauma from the high definition colonoscope alone or with high definition colonoscope with Reveal® cap or Endocuff Vision, perforation or gastrointestinal bleeding (requiring intervention) will be recorded for three groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three Arm Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| High-Definition White-light Colonoscopy | Active comparator | Procedure: ColonoscopyUsing an instrument called colonoscope which is used to detect colonic polyps |
| High-Definition White-light Colonoscopy With Reveal® | Active comparator | Procedure: Colonoscopy, Device: distal CapUsing an instrument called cap at end of colonoscope which is used to straighten colon folds |
| High-Definition White-light Colonoscopy With Endocuff Vision | Active comparator | Procedure: Colonoscopy, Device: EndocuffUsing an instrument called Endocuff at end of colonoscope which is used to straighten colon folds |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referral for screening or surveillance colonoscopy
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- Prior history of colon cancer
- History of inflammatory bowel disease
- Prior surgical resection of any part of the colon
- Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
- History of polyposis syndrome or HNPCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyUsing an instrument called colonoscope which is used to detect colonic polyps | Procedure or surgery | High-Definition White-light Colonoscopy, High-Definition White-light Colonoscopy With Endocuff Vision, High-Definition White-light Colonoscopy With Reveal® |
| distal CapUsing an instrument called cap at end of colonoscope which is used to straighten colon folds | Device | High-Definition White-light Colonoscopy With Reveal® |
| EndocuffUsing an instrument called Endocuff at end of colonoscope which is used to straighten colon folds | Device | High-Definition White-light Colonoscopy With Endocuff Vision |
Primary outcome
Adenoma detection rate
Time frame: Through the study (1 year)
To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
7 secondary outcomes
Number of Adenomas per person
Time frame: Through the study (1 year)
detection rates of advanced adenomas
Time frame: Through the study (1 year)
detect rates of serrated polyps
Time frame: Through the study (1 year)
detect rates of right sided adenomas
Time frame: Through the study (1 year)
to determine cecal intubation time
Time frame: Through the study (1 year)
to determine insertion and withdrawal time
Time frame: Through the study (1 year)
to determine complications
Time frame: Through the study(1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 22237781Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
- Background: PubMed 16697750Winawer SJ, Zauber AG, Fletcher RH, Stillman JS, O'Brien MJ, Levin B, Smith RA, Lieberman DA, Burt RW, Levin TR, Bond JH, Brooks D, Byers T, Hyman N, Kirk L, Thorson A, Simmang C, Johnson D, Rex DK; US Multi-Society Task Force on Colorectal Cancer; American Cancer Society. Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society. Gastroenterology. 2006 May;130(6):1872-85. doi: 10.1053/j.gastro.2006.03.012.
- Background: PubMed 11358901Citarda F, Tomaselli G, Capocaccia R, Barcherini S, Crespi M; Italian Multicentre Study Group. Efficacy in standard clinical practice of colonoscopic polypectomy in reducing colorectal cancer incidence. Gut. 2001 Jun;48(6):812-5. doi: 10.1136/gut.48.6.812.
- Background: PubMed 16454841van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
- Background: PubMed 18389446Heresbach D, Barrioz T, Lapalus MG, Coumaros D, Bauret P, Potier P, Sautereau D, Boustiere C, Grimaud JC, Barthelemy C, See J, Serraj I, D'Halluin PN, Branger B, Ponchon T. Miss rate for colorectal neoplastic polyps: a prospective multicenter study of back-to-back video colonoscopies. Endoscopy. 2008 Apr;40(4):284-90. doi: 10.1055/s-2007-995618.
- Background: PubMed 25470133Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.
- Background: PubMed 21997547Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.
- Background: PubMed 24921209Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166.
- Derived from this study: PubMed 36228700Desai M, Rex DK, Bohm ME, Davitkov P, DeWitt JM, Fischer M, Faulx G, Heath R, Imler TD, James-Stevenson TN, Kahi CJ, Kessler WR, Kohli DR, McHenry L, Rai T, Rogers NA, Sagi SV, Sathyamurthy A, Vennalaganti P, Sundaram S, Patel H, Higbee A, Kennedy K, Lahr R, Stojadinovikj G, Campbell C, Dasari C, Parasa S, Faulx A, Sharma P. Impact of withdrawal time on adenoma detection rate: results from a prospective multicenter trial. Gastrointest Endosc. 2023 Mar;97(3):537-543.e2. doi: 10.1016/j.gie.2022.09.031. Epub 2022 Oct 10.
- Derived from this study: PubMed 34979245Desai M, Rex DK, Bohm ME, Davitkov P, DeWitt JM, Fischer M, Faulx G, Heath R, Imler TD, James-Stevenson TN, Kahi CJ, Kessler WR, Kohli DR, McHenry L, Rai T, Rogers NA, Sagi SV, Sathyamurthy A, Vennalaganti P, Sundaram S, Patel H, Higbee A, Kennedy K, Lahr R, Stojadinovikj G, Dasari C, Parasa S, Faulx A, Sharma P. High-Definition Colonoscopy Compared With Cuff- and Cap-Assisted Colonoscopy: Results From a Multicenter, Prospective, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2023-2031.e6. doi: 10.1016/j.cgh.2021.12.037. Epub 2021 Dec 31.
- Individual participant dataSharing planned: No. This is a multi- center study and we will receive de identified data from other centered via REDCAP
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prateek Sharma, MD principal investigator
Kansas City VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy, distal Cap and Endocuff in people with Colorectal Adenoma, run by Midwest Biomedical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: Through the study (1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03952611, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.