NCT02368977

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

3.9 years

First QC Date

February 11, 2015

Last Update Submit

June 26, 2017

Conditions

Colorectal Neoplasms

Keywords

ColonoscopyPolypsAdenomas

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Device video factors

    1 hour (average duration of procedure)

  • Patient safety assessed by number of subjects with adverse events as a measure of safety and tolerability

    At time of procedure and up to 48 hours after completion of procedure

Study Arms (1)

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.

Device: Third Eye Panoramic device

Interventions

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.

All subjects

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Hospital Queens

Flushing, New York, 11355, United States

Location

Related Publications (1)

  • 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.

    PMID: 26457029DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsPolypsAdenoma

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Moshe Rubin, MD

    New York Hospital Queens - Weill Cornell Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open Label
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 23, 2015

Study Start

November 12, 2013

Primary Completion

October 11, 2017

Study Completion

October 11, 2017

Last Updated

June 27, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)