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Trial record 49 of 65 for:    gastroenterology | Recruiting | Exclude Unknown | United States

Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study (C3PO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by ColoWrap, LLC
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
ColoWrap, LLC
ClinicalTrials.gov Identifier:
NCT02025504
First received: December 28, 2013
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Performance and Tolerance of Colonoscopy
Device: ColoWrap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Efficacy of ColoWrap® Abdominal Binder in Improving Performance and Tolerance of Colonoscopy: a Randomized, Sham-Controlled, Blinded Clinical Trial

Resource links provided by NLM:


Further study details as provided by ColoWrap, LLC:

Primary Outcome Measures:
  • Mean colonoscopic insertion time [ Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified ] [ Designated as safety issue: No ]
    Colonoscopic insertion time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum


Secondary Outcome Measures:
  • Frequency of use of ancillary maneuvers [ Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified ] [ Designated as safety issue: Yes ]
    Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.

  • Frequency of prolonged, difficult cases [ Time Frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum ] [ Designated as safety issue: Yes ]
    The frequency of prolonged, difficult cases. Procedures in which the insertion phase is greater than 20 min will be recorded and indicated as such.

  • Drug and Dosage Required to Complete Procedure [ Time Frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum ] [ Designated as safety issue: Yes ]
    Drug and dosage amount required by patient to complete colonoscopy.

  • Colonoscopy Completion Rate [ Time Frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum ] [ Designated as safety issue: Yes ]
    Colonoscopy completion rate. Dichotomous outcome indicating if the procedure was incomplete or complete.

  • Time to patient discharge [ Time Frame: From time point in which scope is removed from patient's rectum following a colonoscopy until the time the patient is discharged from the facility ] [ Designated as safety issue: No ]
    Time to discharge, defined as the time from withdrawal of the colonoscope to patient discharge from the endoscopy unit.

  • Operator perception of patient discomfort [ Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified ] [ Designated as safety issue: No ]
    Immediately following completion of procedure, ColoWrap study assistant will obtain operator perception of patient discomfort during procedure according to the Gloucester score

  • Patient Pain, Bloating, and Satisfaction at Discharge [ Time Frame: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility ] [ Designated as safety issue: No ]
    The ColoWrap study assistant will interview patient just prior to discharge and obtain responses for pain and bloating according to 10-point visual analog scales, and global satisfaction according to a 5-point scale.

  • Operator's Assessment of Procedural Difficultly [ Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified ] [ Designated as safety issue: Yes ]
    Immediately following completion of procedure, the study assistant will obtain the operator's assessment of procedural difficulty and level of physical fatigue according to 5-point scales.

  • Assistant/Technician's Assessment of Musculoskeletal Pain Following Procedure [ Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified ] [ Designated as safety issue: Yes ]
    The study assistant will ask the endoscopy technician if they experienced pain during the procedure in any of the following four anatomical sites: lower back, upper back, neck, or upper extremities (right and left shoulder, arm, wrist, hand, fingers). This frequency data will be dichotomous.


Other Outcome Measures:
  • Patient Assessment of Intra-Procedural Pain [ Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified ] [ Designated as safety issue: No ]
    For patients undergoing colonoscopy with conscious sedation, the study assistant will also obtain a response for intra-procedural pain, using a validated measure of procedural comfort.


Estimated Enrollment: 350
Study Start Date: April 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ColoWrap Intervention Group
Patients randomized to ColoWrap Intervention Group will have the ColoWrap abdominal binder secured firmly around their lower abdomen just prior to colonoscopy.
Device: ColoWrap
ColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy.
Other Names:
  • ColoWrap abdominal binder
  • ColoWrap colonoscopy binder
  • ColoWrap device
  • ColoWrap binder
Sham Comparator: Sham Group
Sham Group will also have a ColoWrap binder placed around their lower abdomen, but it will be placed loosely so no appreciable lower abdominal pressure is generated by the device.
Device: ColoWrap
ColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy.
Other Names:
  • ColoWrap abdominal binder
  • ColoWrap colonoscopy binder
  • ColoWrap device
  • ColoWrap binder

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female adults between the ages of 40 - 80
  • Undergoing a colonoscopy at any of the study locations for:

    i. CRC screening (first colonoscopy or 10 year follow up of negative exam). ii. Surveillance (prior colonoscopy with polyps). iii. Diagnostic colonoscopy performed to evaluate symptoms such as abdominal pain or rectal bleeding.

  • Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.
  • For the purposes of informed consent, participants must be able to understand and read English.

Exclusion Criteria:

  • Inability to provide informed consent
  • Active or suspected pregnancy
  • Patients referred due to incomplete colonoscopy or for removal of difficult polyps
  • History of problems with sedation or anesthesia -. Participants electing to be unsedated for colonoscopy
  • Patients undergoing multiple procedures (e.g. upper and lower endoscopy)
  • Previous colon resection surgery
  • Patients with known or suspected diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
  • Patients with a history of colorectal cancer or other intra-abdominal malignancy.
  • Patients with open or recent wounds or skin rash on the anterior abdominal wall.
  • History of cirrhosis or ascites
  • Known ventral or umbilical hernia
  • Patients who are medically unstable(American Society of Anesthesiology Class III or above).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025504

Contacts
Contact: Seth D Crockett, MD, MPH 919-962-2608 seth_crockett@med.unc.edu

Locations
United States, North Carolina
UNC Hospitals Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
Principal Investigator: Seth D Crockett, MD MPH         
UNC Meadowmont Endoscopy Center Recruiting
Chapel Hill, North Carolina, United States, 27517
Principal Investigator: Seth D Crockett, MD MPH         
UNC Hillsborough Endoscopy Center Not yet recruiting
Hillsborough, North Carolina, United States, 27278
Principal Investigator: Seth D Crockett, MD MPH         
Sponsors and Collaborators
ColoWrap, LLC
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Seth D Crockett, MD, MPH Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC
  More Information

No publications provided

Responsible Party: ColoWrap, LLC
ClinicalTrials.gov Identifier: NCT02025504     History of Changes
Other Study ID Numbers: ColoWrap-002
Study First Received: December 28, 2013
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ColoWrap, LLC:
Colonoscopy, Looping, Sigmoid Looping, ColoWrap, Binder, Patient Satisfaction

ClinicalTrials.gov processed this record on November 25, 2014