Third Eye Panoramic Device Feasibility Evaluation

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Device: Third Eye Panoramic device

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Flushing, New York, United States, 11355
      • New York Hospital Queens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup.
2. The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

1. Patients >75 years of age;
2. Patients with a history of colonic resection;
3. Patients with suspected chronic stricture potentially precluding complete colonoscopy;
4. Patients with diverticulitis or toxic megacolon;
5. Patients with a history of radiation therapy to abdomen or pelvis;
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; 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.	Device: Third Eye Panoramic device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device usability factors	Device usability as measured by investigators' qualitative impressions regarding ease of use and any potential interference with function of colonoscope.	1 hour (average duration of procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device video factors	Video image quality and ability to view areas behind folds as measured by investigators' qualitative impressions	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	At time of procedure and up to 48 hours after completion of procedure

Collaborators and Investigators

• Sponsor: Avantis Medical Systems
• Investigators: Principal Investigator: Moshe Rubin, MD, New York Hospital Queens - Weill Cornell Medical College

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2013
• Primary Completion (Anticipated): October 11, 2017
• Study Completion (Anticipated): October 11, 2017

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Colonoscopy; Adenomas; Polyps
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Avantis TEP 13-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO