Performance and Tolerance of ColonoscopyC3PONCT02025504
Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study
A study testing ColoWrap in people with Performance and Tolerance of Colonoscopy, run by ColoWrap, LLC at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Performance and Tolerance of Colonoscopy
- What is being tested?
- ColoWrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to Mar 2015
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults between the ages of 40 - 80
- Undergoing a colonoscopy at any of the study locations for:
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UNC Hospitals
Chapel Hill, North Carolina, 27514
UNC Meadowmont Endoscopy Center
Chapel Hill, North Carolina, 27517
UNC Hillsborough Endoscopy Center
Hillsborough, North Carolina, 27278
About this study
Official title: Efficacy of ColoWrap® Abdominal Binder in Improving Performance and Tolerance of Colonoscopy: a Randomized, Sham-Controlled, Blinded Clinical Trial
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.
- Conditions
- Performance and Tolerance of Colonoscopy
- Being tested
- ColoWrap
- Keywords
- Colonoscopy, Looping, Sigmoid Looping, ColoWrap, Binder, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColoWrapDevice
Also called ColoWrap abdominal binder, ColoWrap colonoscopy binder, ColoWrap device, ColoWrap binder
ColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| ColoWrap Intervention Group | Experimental | Patients randomized to ColoWrap Intervention Group will have the ColoWrap abdominal binder secured firmly around their lower abdomen just prior to colonoscopy. Receives: Device: ColoWrap |
| Sham Group | Sham comparator | 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. Receives: Device: ColoWrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean colonoscopic insertion time
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
Measured: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Secondary outcomes (9)
Frequency of use of ancillary maneuvers
Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.
Measured: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Frequency of prolonged, difficult cases
The frequency of prolonged, difficult cases. Procedures in which the insertion phase is greater than 20 min will be recorded and indicated as such.
Measured: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Drug and Dosage Required to Complete Procedure
Drug and dosage amount required by patient to complete colonoscopy.
Measured: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Colonoscopy Completion Rate
Colonoscopy completion rate. Dichotomous outcome indicating if the procedure was incomplete or complete.
Measured: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Time to patient discharge
Time to discharge, defined as the time from withdrawal of the colonoscope to patient discharge from the endoscopy unit.
Measured: 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
Operator perception of patient discomfort
Immediately following completion of procedure, ColoWrap study assistant will obtain operator perception of patient discomfort during procedure according to the Gloucester score
Measured: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Patient Pain, Bloating, and Satisfaction at Discharge
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.
Measured: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility
Operator's Assessment of Procedural Difficultly
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.
Measured: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Assistant/Technician's Assessment of Musculoskeletal Pain Following Procedure
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.
Measured: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Performance and Tolerance of ColonoscopyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- ColoWrap, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Seth D Crockett, MD, MPH, Principal investigator, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025504
- Sponsor's protocol ID
- ColoWrap-002
- Acronym
- C3PO
- Status last verified
- Mar 2015
- First submitted
- 28 Dec 2013
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crockett S, Dellon ES, Biggers L, Ernst DA. Use of Patient Abdominal Compression Device Reduces Staff Musculoskeletal Pain Associated With Supporting Colonoscopy: Results From a Randomized Controlled Trial. Gastroenterol Nurs. 2021 Mar-Apr 01;44(2):136-145. doi: 10.1097/SGA.0000000000000550.
PubMed 33795622Crockett SD, Cirri HO, Kelapure R, Galanko JA, Martin CF, Dellon ES. Use of an Abdominal Compression Device in Colonoscopy: A Randomized, Sham-Controlled Trial. Clin Gastroenterol Hepatol. 2016 Jun;14(6):850-857.e3. doi: 10.1016/j.cgh.2015.12.039. Epub 2016 Jan 6.
PubMed 26767313
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ColoWrap® Abdominal Binder in Improving Performance and Tolerance of Colonoscopy: a Randomized, Sham-Controlled, Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT02025504
- Acronym / sponsor ID
- C3PO / ColoWrap-002
- Conditions
- Performance and Tolerance of Colonoscopy
- Keywords
- Colonoscopy, Looping, Sigmoid Looping, ColoWrap, Binder, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- ColoWrap, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Jan 2014 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ColoWrap Intervention Group | Experimental | Device: ColoWrapPatients randomized to ColoWrap Intervention Group will have the ColoWrap abdominal binder secured firmly around their lower abdomen just prior to colonoscopy. |
| Sham Group | Sham comparator | Device: ColoWrapSham 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female adults between the ages of 40 - 80
- Undergoing a colonoscopy at any of the study locations for:
- 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.
Key exclusion criteria (12 listed)
- 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)
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 |
|---|---|---|
| ColoWrapAlso: ColoWrap abdominal binder, ColoWrap colonoscopy binder, ColoWrap device, ColoWrap binderColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy. | Device | ColoWrap Intervention Group, Sham Group |
Primary outcome
Mean colonoscopic insertion time
Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
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
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 33795622Crockett S, Dellon ES, Biggers L, Ernst DA. Use of Patient Abdominal Compression Device Reduces Staff Musculoskeletal Pain Associated With Supporting Colonoscopy: Results From a Randomized Controlled Trial. Gastroenterol Nurs. 2021 Mar-Apr 01;44(2):136-145. doi: 10.1097/SGA.0000000000000550.
- Derived from this study: PubMed 26767313Crockett SD, Cirri HO, Kelapure R, Galanko JA, Martin CF, Dellon ES. Use of an Abdominal Compression Device in Colonoscopy: A Randomized, Sham-Controlled Trial. Clin Gastroenterol Hepatol. 2016 Jun;14(6):850-857.e3. doi: 10.1016/j.cgh.2015.12.039. Epub 2016 Jan 6.
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.
Seth D Crockett, MD, MPH principal investigator
Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ColoWrap in people with Performance and Tolerance of Colonoscopy, run by ColoWrap, LLC at 3 sites 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean colonoscopic insertion time (time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified). 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 NCT02025504, which also lists 2 linked publications.
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 3 Apr 2015.