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Clinical trialNCT02025504CompletedInterventional

Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study

SponsorColoWrap, LLCEnrollment350Performance and Tolerance of Colonoscopy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due to variations in patient anatomy, tortuous colons, and looping of the endoscope. Such obstacles can prolong colonoscopy, lead to complications, decrease polyp detection, and impact patient experience and tolerance. The investigators propose to evaluate the efficacy of a new non-invasive abdominal binder (ColoWrap®) in improving the performance and tolerance of colonoscopy by way of a randomized, blinded clinical trial. Eligible participants undergoing colonoscopy at University of North Carolina Hospitals (UNCH) will be recruited for the study and randomized to either the ColoWrap intervention or sham arm. Colonoscopy will be performed per usual operating procedures. The primary outcome will be time to distal extent (cecal intubation time). Secondary outcomes include colonoscopy completion rate, use of ancillary maneuvers, medication usage, procedural difficulty, patient comfort, and operator and assistant fatigue and pain. Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Seth D Crockett, MD, MPH

    Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Unc Hospitals

    Chapel Hill, North Carolina, United States

  • Unc Meadowmont Endoscopy Center

    Chapel Hill, North Carolina, United States

  • Unc Hillsborough Endoscopy Center

    Hillsborough, North Carolina, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Apr 2014
Primary completion
31 Mar 2015
Completion
31 Mar 2015
Last update posted
3 Apr 2015
Registered enrollment
350
Registry id
NCT02025504

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 30 Jul 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.