Redundant ColonNCT02359409
Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy
A study testing goggle balloon and water immersion only in people with Redundant Colon, run by Indiana University at 1 site in United States.
Trial summary
This study aims to look if use of goggle balloon can help to complete colonoscopy in patients with very redundant colons. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Redundant Colon
- What is being tested?
- goggle balloon and water immersion only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 28 Mar 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Referral for incomplete colonoscopy
Who cannot join
- Known stricture or narrowing of the colon, prior colon resection
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
This study aims to look if use of goggle balloon can help to complete colonoscopy in patients with very redundant colons.
Read the detailed description
About 5% of colonoscopies are technically difficult because the colon is elongated or redundant. There is an increased risk of the colonoscope not reaching the cecum in these cases. One solution to this is to try to keep the colon shorter by not insufflating it with gas. In order to achieve that, in these cases the investigators typically fill the colon with water, which does not distend the colon as much. Another technique, which can improve visualization, is to use a device called the goggle balloon. This is a small balloon filled with a few mL of water which fits over the end of the colonoscope and pushes the colonic mucosa away from the end of the scope so that the luminal direction can be visualized with minimal insufflation. In patients with normal colons, the goggle balloon can be used to insert the colonoscope to the cecum with virtually no air or water filling. We aim to study if the goggle balloon can be used to help complete the colonoscopy in patients with redundant colons.
- Conditions
- Redundant Colon
- Being tested
- goggle balloon, water immersion only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
goggle balloonDevice
Colonoscopy will be performed using the water immersion technique.
water immersion onlyOther
Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique.
| Study group | Role | What they receive |
|---|---|---|
| water immersion only | Active comparator | Colonoscopy will be performed using the water immersion technique. Receives: Other: water immersion only |
| water immersion with goggle balloon | Experimental | Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique Receives: Device: goggle balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of subjects with complete colonoscopy in each arm
Measured: 2 years
Secondary outcomes (1)
Time to cecal intubation in each arm
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJul 2014
- Primary completion28 Mar 2017
- Study completion28 Mar 2017
Why it stopped: no subjects consented due to competing studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Redundant ColonStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas K. Rex, Indiana University
- Investigators
- Douglas K Rex, MD, Principal investigator, IU Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359409
- Sponsor's protocol ID
- IndianaU
- Status last verified
- Apr 2017
- First submitted
- 30 Jan 2015
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy
- ClinicalTrials.gov ID
- NCT02359409
- Acronym / sponsor ID
- IndianaU
- Conditions
- Redundant Colon
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no subjects consented due to competing studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 28 Mar 2017 (actual)
- First posted
- 10 Feb 2015 (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.
This study aims to look if use of goggle balloon can help to complete colonoscopy in patients with very redundant colons.
Detailed description
About 5% of colonoscopies are technically difficult because the colon is elongated or redundant. There is an increased risk of the colonoscope not reaching the cecum in these cases. One solution to this is to try to keep the colon shorter by not insufflating it with gas. In order to achieve that, in these cases the investigators typically fill the colon with water, which does not distend the colon as much. Another technique, which can improve visualization, is to use a device called the goggle balloon. This is a small balloon filled with a few mL of water which fits over the end of the colonoscope and pushes the colonic mucosa away from the end of the scope so that the luminal direction can be visualized with minimal insufflation. In patients with normal colons, the goggle balloon can be used to insert the colonoscope to the cecum with virtually no air or water filling. We aim to study if the goggle balloon can be used to help complete the colonoscopy in patients with redundant colons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| water immersion only | Active comparator | Other: water immersion onlyColonoscopy will be performed using the water immersion technique. |
| water immersion with goggle balloon | Experimental | Device: goggle balloonColonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referral for incomplete colonoscopy
Key exclusion criteria (1 listed)
- Known stricture or narrowing of the colon, prior colon resection
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 |
|---|---|---|
| goggle balloonColonoscopy will be performed using the water immersion technique. | Device | water immersion with goggle balloon |
| water immersion onlyColonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique. | Other | water immersion only |
Primary outcome
number of subjects with complete colonoscopy in each arm
Time frame: 2 years
1 secondary outcome
Time to cecal intubation in each arm
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: No
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.
Douglas K Rex, MD principal investigator
IU Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing goggle balloon and water immersion only in people with Redundant Colon, run by Indiana University at 1 site 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
number of subjects with complete colonoscopy in each arm (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2017.