Colonic Adenomatous PolypsNCT02051465
Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM
A study testing LumenR Retractor and Removal without overtube in people with Colonic Adenomatous Polyps, run by Mercy Medical Center at 1 site in United States.
Trial summary
Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in 2010 and worldwide has become the third most common cancer and second leading cause of cancer related deaths. Read more about this study
- Who is it for?
- Ages 17 to 90 years
- Conditions the study is for
- Colonic Adenomatous Polyps
- What is being tested?
- LumenR Retractor and Removal without overtube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2017
- 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 17 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Colonic polyps 2cm in size or greater
- Subject 17 to 90 years of age
- Female subjects must have negative pregnancy test within last 24 hours timeline, and no intentions to become pregnant or be sterilized during participation in study.
Who cannot join
- Colonic polyps less than 2cm in size
- Under 17 or over 90 years of age
- Unwilling to consent or comply with protocol requirements
- Uncorrectable bleeding disorders (INR more than 1.5; platlet count less than 50,000)
- Allergy to materials from which the device is constructed- Polyvinyl Chloride, Nitinol, Watershed, Polycarbonate, and Polytetrafluoroethylene
- Received experimental drug or device within 3 months prior to start of study
Show all 9Show fewer
- Treatment with an investigational drug or medical device during the study period
- Female subjects that are pregnant or lactating or intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study
- Psychological condition, or under treatment for any condition which, in the opinion of the Investigator and/or consulting physician(s), would constitute an unwarranted risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM (LR) as a Modified Colonic Overtube
Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in 2010 and worldwide has become the third most common cancer and second leading cause of cancer related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer and endoscopic removal of the polyps prevents development of colon cancer.
Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically difficult to perform, labor intensive, time consuming and carries higher risks of complications (bleeding, perforations, etc.). The purpose of this study is to determine the effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is hypothesized that the use of this modified colonic overtube will simplify colonoscopic removal of difficult polyps, decrease the time needed to complete the procedure and decrease the rate of complications post endoscopic removal of large and flat colonic.
Read the detailed description
All patients presented for endoscopic removal of difficult colonic polyps will be eligible for the study based on inclusion and exclusion criteria. All procedures will be explained by the Investigator and all subjects undergoing treatment will review and sign the study Informed Consent prior to the procedure. Each subject will be randomly assigned to two groups, Group 1 and Group 2, and according to the assignment, the LumenR Retractor will be used or not during the procedure.
Patient preparation, including intravenous sedation, will be the same for both Groups.
Group 1: A traditional pediatric colonoscope will be advanced into the colon and endoscopic removal of the polyp will be performed.
Group 2: A traditional pediatric colonoscope with a modified overtube preloaded over the endoscope will be advanced into the colon. After the polyp is reached, the overtube will be advanced forward and expanded around the polyp. Endoscopic removal of the polyp with the use of commercially available graspers and biopsy forceps inserted through the overtube working channels will be performed.
At the conclusion of each procedure, the size of the polyp, total procedure time, amount of CO2 used for colonic insufflation, amount of fluid used for submucosal injection, and any complications, including bleeding and perforation, will be recorded. At the end of the procedure, if necessary, the resulting mucosal defect after lesion removal will be closed with endoscopic clips or endoscopic suturing device.
After completion of procedure, all subjects will be recovered according to standard recovery room protocol and then discharged home or admitted to hospital if necessary. Subjects will be followed at 24 hours, and 10 days post treatment and any complications post endoscopic removal of the polyp will be recorded. At 3 months post treatment, all subjects will have repeat colonoscopy to evaluate post polypectomy site and remove any residual polypoid tissue found.
- Conditions
- Colonic Adenomatous Polyps
- Being tested
- LumenR Retractor, Removal without overtube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumenR RetractorDevice
Polyp removal using LumenR Retractor Modified overtube
Removal without overtubeDevice
Endoscopic removal of polyp without overtube
| Study group | Role | What they receive |
|---|---|---|
| LumenR Retractor | Experimental | Endoscopic removal of polyp using modified overtube LumenR Retractor Receives: Device: LumenR Retractor |
| Removal without overtube | Active comparator | Endoscopic removal of polyp without overtube Receives: Device: Removal without overtube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successful en block removal of polyps
Measured: 1 year
Length of time required to remove large and flat colonic polyps
Measured: Day 1
Secondary outcomes (6)
Amount of carbon dioxide (CO2) gas for colonic insufflation used during procedure
Measured: Day 1
Amount of solution used for submucosal injection to lift the polyp
Measured: Day 1
Presence of residual polypoid tissue at the site of polypectomy
A colonoscopy will be performed to evaluate the polypectomy site and remove any residual polypoid tissue if found.
Measured: 3 months
Safety assessment based on the number of delayed adverse events and complications
Measured: 10 days
Rate of bleeding during polypectomy
Estimate of rate of bleeding during endoscopic removal of difficult colonic polyps
Measured: 1 year
Rate of perforation during polypectomy
To compare rate of perforation during endoscopic removal of difficult colonic polyps
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic Adenomatous PolypsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergey Kantsevoy, Mercy Medical Center
- Investigators
- Sergey V Kantsevoy, M.D., Ph.D., Principal investigator, Mercy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051465
- Sponsor's protocol ID
- MMC 2012-64
- Status last verified
- Aug 2018
- First submitted
- 26 Jan 2014
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM (LR) as a Modified Colonic Overtube
- ClinicalTrials.gov ID
- NCT02051465
- Acronym / sponsor ID
- MMC 2012-64
- Conditions
- Colonic Adenomatous Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mercy Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in 2010 and worldwide has become the third most common cancer and second leading cause of cancer related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer and endoscopic removal of the polyps prevents development of colon cancer.
Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically difficult to perform, labor intensive, time consuming and carries higher risks of complications (bleeding, perforations, etc.). The purpose of this study is to determine the effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is hypothesized that the use of this modified colonic overtube will simplify colonoscopic removal of difficult polyps, decrease the time needed to complete the procedure and decrease the rate of complications post endoscopic removal of large and flat colonic.
Detailed description
All patients presented for endoscopic removal of difficult colonic polyps will be eligible for the study based on inclusion and exclusion criteria. All procedures will be explained by the Investigator and all subjects undergoing treatment will review and sign the study Informed Consent prior to the procedure. Each subject will be randomly assigned to two groups, Group 1 and Group 2, and according to the assignment, the LumenR Retractor will be used or not during the procedure.
Patient preparation, including intravenous sedation, will be the same for both Groups.
Group 1: A traditional pediatric colonoscope will be advanced into the colon and endoscopic removal of the polyp will be performed.
Group 2: A traditional pediatric colonoscope with a modified overtube preloaded over the endoscope will be advanced into the colon. After the polyp is reached, the overtube will be advanced forward and expanded around the polyp. Endoscopic removal of the polyp with the use of commercially available graspers and biopsy forceps inserted through the overtube working channels will be performed.
At the conclusion of each procedure, the size of the polyp, total procedure time, amount of CO2 used for colonic insufflation, amount of fluid used for submucosal injection, and any complications, including bleeding and perforation, will be recorded. At the end of the procedure, if necessary, the resulting mucosal defect after lesion removal will be closed with endoscopic clips or endoscopic suturing device.
After completion of procedure, all subjects will be recovered according to standard recovery room protocol and then discharged home or admitted to hospital if necessary. Subjects will be followed at 24 hours, and 10 days post treatment and any complications post endoscopic removal of the polyp will be recorded. At 3 months post treatment, all subjects will have repeat colonoscopy to evaluate post polypectomy site and remove any residual polypoid tissue found.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LumenR Retractor | Experimental | Device: LumenR RetractorEndoscopic removal of polyp using modified overtube LumenR Retractor |
| Removal without overtube | Active comparator | Device: Removal without overtubeEndoscopic removal of polyp without overtube |
Who may qualify
- Ages
- 17 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Colonic polyps 2cm in size or greater
- Subject 17 to 90 years of age
- Female subjects must have negative pregnancy test within last 24 hours timeline, and no intentions to become pregnant or be sterilized during participation in study.
Key exclusion criteria (9 listed)
- Colonic polyps less than 2cm in size
- Under 17 or over 90 years of age
- Unwilling to consent or comply with protocol requirements
- Uncorrectable bleeding disorders (INR more than 1.5; platlet count less than 50,000)
- Allergy to materials from which the device is constructed- Polyvinyl Chloride, Nitinol, Watershed, Polycarbonate, and Polytetrafluoroethylene
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 |
|---|---|---|
| LumenR RetractorPolyp removal using LumenR Retractor Modified overtube | Device | LumenR Retractor |
| Removal without overtubeEndoscopic removal of polyp without overtube | Device | Removal without overtube |
Primary outcome
Percentage of successful en block removal of polyps
Time frame: 1 year
Length of time required to remove large and flat colonic polyps
Time frame: Day 1
6 secondary outcomes
Amount of carbon dioxide (CO2) gas for colonic insufflation used during procedure
Time frame: Day 1
Amount of solution used for submucosal injection to lift the polyp
Time frame: Day 1
Presence of residual polypoid tissue at the site of polypectomy
Time frame: 3 months
Safety assessment based on the number of delayed adverse events and complications
Time frame: 10 days
Rate of bleeding during polypectomy
Time frame: 1 year
Rate of perforation during polypectomy
Time frame: 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 21 Aug 2018.
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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.
Sergey V Kantsevoy, M.D., Ph.D. principal investigator
Mercy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LumenR Retractor and Removal without overtube in people with Colonic Adenomatous Polyps, run by Mercy Medical Center 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 3 inclusion and 9 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 21 Aug 2018. 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?
Percentage of successful en block removal of polyps (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2018.