Colorectal NeoplasmsNCT02368977
Third Eye Panoramic Device Feasibility Evaluation
A study testing Third Eye Panoramic device in people with Colorectal Neoplasms, run by Avantis Medical Systems at 1 site in United States.
Trial summary
This study will evaluate the feasibility of using the Third Eye Panoramic device in conjunction with standard colonoscopes in a clinical setting. Patients will undergo a colonoscopy procedure during which the study device will provide video imaging of areas of the colon that are difficult to evaluate with the… Read more about this study
- Who is it for?
- Ages Up to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Third Eye Panoramic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2013to 11 Oct 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 Up to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup.
- The patient must understand and provide written consent for the procedure.
Who cannot join
- Patients >75 years of age;
- Patients with a history of colonic resection;
- Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- Patients with diverticulitis or toxic megacolon;
- Patients with a history of radiation therapy to abdomen or pelvis;
- Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the feasibility of using the Third Eye Panoramic device in conjunction with standard colonoscopes in a clinical setting.
Patients will undergo a colonoscopy procedure during which the study device will provide video imaging of areas of the colon that are difficult to evaluate with the colonoscope alone.
The utility of the device will be assessed from the impressions of the investigators and from telephone follow-up with subjects to assess for post-procedural complications.
Read the detailed description
The purpose of this study is to evaluate the feasibility of using the Third Eye Panoramic device along with a standard colonoscope as a means of enhancing the ability of endoscopists to view areas that are hidden from the view of the colonoscope.
Colonoscopy is generally agreed to be the best method for detecting and removing cancers and pre-cancerous adenomas in the colon. However, numerous studies have demonstrated that from 22% to over 40% of adenomas are missed during standard colonoscopy. More importantly, 12% of large adenomas (at least 1 cm) are missed even by expert endoscopists using meticulous technique with the best available equipment, and these large adenomas are the ones that are most likely to transform into cancer.
Factors such as quality of bowel cleansing and time spent examining the colonic mucosa have been shown to affect miss rates. However, comparison with the results of CT colonography has shown that 2/3 of missed adenomas are located behind folds in the wall of the colon, in areas that are very difficult to see with a standard forward-viewing colonoscope.
When clipped onto the tip of a standard colonoscope, the Third Eye Panoramic device provides two additional miniature video cameras and light sources that offer views to the left side and right side of the colonoscope's tip. These lateral views complement the forward view of the colonoscope's camera to result in a "panoramic" view of over 300°. This extreme wide-angle view allows the endoscopist to examine the areas located behind folds.
In this study, each subject will undergo a colonoscopy procedure utilizing the Third Eye Panoramic device along with a standard colonoscope.
The investigators will evaluate issues related to usability and safety based on their experience and impressions, with telephone follow-up with subjects to assess for any post-procedural complications.
- Conditions
- Colorectal Neoplasms
- Being tested
- Third Eye Panoramic device
- Keywords
- Colonoscopy, Polyps, Adenomas
- Medical subject headings
- Colorectal Neoplasms, Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third Eye Panoramic deviceDevice
A Third Eye Panoramic device will be attached to the tip of the colonoscope and will provide two additional views from laterally-oriented video cameras during the colonoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | All subjects will undergo examination with a Third Eye Panoramic device in conjunction with a standard colonoscope to evaluate the feasibility of using the study device to provide video imaging of areas of the colon that are difficult to evaluate with the colonoscope alone. Receives: Device: Third Eye Panoramic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device usability factors
Device usability as measured by investigators' qualitative impressions regarding ease of use and any potential interference with function of colonoscope.
Measured: 1 hour (average duration of procedure)
Secondary outcomes (2)
Device video factors
Video image quality and ability to view areas behind folds as measured by investigators' qualitative impressions
Measured: 1 hour (average duration of procedure)
Patient safety assessed by number of subjects with adverse events as a measure of safety and tolerability
Number of subjects with adverse events
Measured: At time of procedure and up to 48 hours after completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study start12 Nov 2013
- Primary completion11 Oct 2017 (estimated)
- Study completion11 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avantis Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moshe Rubin, MD, Principal investigator, New York Hospital Queens - Weill Cornell Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368977
- Sponsor's protocol ID
- Avantis TEP 13-01
- Status last verified
- Jun 2017
- First submitted
- 11 Feb 2015
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rubin M, Lurie L, Bose K, Kim SH. Expanding the view of a standard colonoscope with the Third Eye Panoramic cap. World J Gastroenterol. 2015 Oct 7;21(37):10683-7. doi: 10.3748/wjg.v21.i37.10683.
PubMed 26457029
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Eye Panoramic Device Feasibility Evaluation
- ClinicalTrials.gov ID
- NCT02368977
- Acronym / sponsor ID
- Avantis TEP 13-01
- Conditions
- Colorectal Neoplasms
- Keywords
- Colonoscopy, Polyps, Adenomas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Avantis Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2013 (actual)
- Primary completion
- 11 Oct 2017 (estimated)
- Study completion
- 11 Oct 2017 (estimated)
- First posted
- 23 Feb 2015 (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.
This study will evaluate the feasibility of using the Third Eye Panoramic device in conjunction with standard colonoscopes in a clinical setting.
Patients will undergo a colonoscopy procedure during which the study device will provide video imaging of areas of the colon that are difficult to evaluate with the colonoscope alone.
The utility of the device will be assessed from the impressions of the investigators and from telephone follow-up with subjects to assess for post-procedural complications.
Detailed description
The purpose of this study is to evaluate the feasibility of using the Third Eye Panoramic device along with a standard colonoscope as a means of enhancing the ability of endoscopists to view areas that are hidden from the view of the colonoscope.
Colonoscopy is generally agreed to be the best method for detecting and removing cancers and pre-cancerous adenomas in the colon. However, numerous studies have demonstrated that from 22% to over 40% of adenomas are missed during standard colonoscopy. More importantly, 12% of large adenomas (at least 1 cm) are missed even by expert endoscopists using meticulous technique with the best available equipment, and these large adenomas are the ones that are most likely to transform into cancer.
Factors such as quality of bowel cleansing and time spent examining the colonic mucosa have been shown to affect miss rates. However, comparison with the results of CT colonography has shown that 2/3 of missed adenomas are located behind folds in the wall of the colon, in areas that are very difficult to see with a standard forward-viewing colonoscope.
When clipped onto the tip of a standard colonoscope, the Third Eye Panoramic device provides two additional miniature video cameras and light sources that offer views to the left side and right side of the colonoscope's tip. These lateral views complement the forward view of the colonoscope's camera to result in a "panoramic" view of over 300°. This extreme wide-angle view allows the endoscopist to examine the areas located behind folds.
In this study, each subject will undergo a colonoscopy procedure utilizing the Third Eye Panoramic device along with a standard colonoscope.
The investigators will evaluate issues related to usability and safety based on their experience and impressions, with telephone follow-up with subjects to assess for any post-procedural complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: Third Eye Panoramic deviceAll subjects will undergo examination with a Third Eye Panoramic device in conjunction with a standard colonoscope to evaluate the feasibility of using the study device to provide video imaging of areas of the colon that are difficult to evaluate with the colonoscope alone. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup.
- The patient must understand and provide written consent for the procedure.
Key exclusion criteria (6 listed)
- Patients >75 years of age;
- Patients with a history of colonic resection;
- Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- Patients with diverticulitis or toxic megacolon;
- Patients with a history of radiation therapy to abdomen or pelvis;
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 |
|---|---|---|
| Third Eye Panoramic deviceA Third Eye Panoramic device will be attached to the tip of the colonoscope and will provide two additional views from laterally-oriented video cameras during the colonoscopy procedure. | Device | All subjects |
Primary outcome
Device usability factors
Time frame: 1 hour (average duration of procedure)
Device usability as measured by investigators' qualitative impressions regarding ease of use and any potential interference with function of colonoscope.
2 secondary outcomes
Device video factors
Time frame: 1 hour (average duration of procedure)
Patient safety assessed by number of subjects with adverse events as a measure of safety and tolerability
Time frame: At time of procedure and up to 48 hours after completion of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Derived from this study: PubMed 26457029Rubin M, Lurie L, Bose K, Kim SH. Expanding the view of a standard colonoscope with the Third Eye Panoramic cap. World J Gastroenterol. 2015 Oct 7;21(37):10683-7. doi: 10.3748/wjg.v21.i37.10683.
- Individual participant dataSharing planned: No
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study
Colorectal Cancer (CRC)
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Not yet recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
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.
Moshe Rubin, MD principal investigator
New York Hospital Queens - Weill Cornell Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Third Eye Panoramic device in people with Colorectal Neoplasms, run by Avantis Medical Systems 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 6 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: status not confirmed, as of the sponsor's last update on 27 Jun 2017. 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?
Results are not available in the source record.
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?
Device usability factors (time frame: 1 hour (average duration of procedure)). 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 NCT02368977, which also lists 1 linked publication.
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 27 Jun 2017.