Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2)NCT06776913
Randomized Controlled Trial Comparing Adult to Pediatric Colonoscope in Obese Patients.
A study testing Colonoscopy in people with Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2) and Screening Colonoscopy, run by Cleveland Clinic Florida at 1 site in United States.
Trial summary
The goal of this study is to test which colonoscope works best in people who are above a certain body mass index. Currently, both pediatric and adult colonoscopes are accepted as standard treatments in colonoscopies. Endoscopist pick which one to use based on personal preference and what is available. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2), Screening Colonoscopy
- What is being tested?
- Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BMI greater than 30
- Screening and surveillance colonoscopy
Who cannot join
- Colon surgery
- Therapeutic colonoscopy
- Inflammatory bowel disease
- Terminated procedure due to stool burden, stenosis, or obstructive mass.
- Colonoscopy for anemia
- History of incomplete colonoscopy due to technical difficulties
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to test which colonoscope works best in people who are above a certain body mass index. Currently, both pediatric and adult colonoscopes are accepted as standard treatments in colonoscopies. Endoscopist pick which one to use based on personal preference and what is available.
- Being tested
- Colonoscopy
- Keywords
- obesity, Screening Colonoscopy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDevice
Standard Colonoscopy with photo documentation and the recording of procedure timing.
| Study group | Role | What they receive |
|---|---|---|
| Adult Colonoscope | Active comparator | Standard colonoscopy performed with adult colonoscope. Receives: Device: Colonoscopy |
| Pediatric Colonoscope | Active comparator | Standard colonoscopy performed with pediatric colonoscope. Receives: Device: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Reaching the Cecum in Less Than 10 Minutes Without Changing the Scope Type.
The outcome aims to measure the difficult colonoscope which is defined as either not reaching the cecum, needing more than 10 minutes, or the need to exchange to a different device.
Measured: During Surgery, up to 10 minutes
Secondary outcomes (5)
Number of Participants With Successful Advancement of Colonoscope to the Cecum
Number of Participants with successful advancement of colonoscope to the cecum. Cecal intubation rate (CIR)
Measured: During Surgery
Number of Participants With Successful Advancement of Colonoscope to the Terminal Ileum
Number of Participants with successful advancement of colonoscope to the terminal ileum. Terminal ileum intubation rate (TIIR)
Measured: During Surgery
Time Taken to Advance the Colonoscope From the Rectum to the Cecum.
Time taken to advance the colonoscope from the rectum to the cecum. Insertion time (IT)
Measured: During Surgery
Time Taken to Withdraw Colonoscope From Cecum to Rectum (Withdrawal Time)
Time from terminal ileum picture or last cecal picture to rectal picture. Subtract 1 min per each intervention (polypectomy, cauterization...)
Measured: During Surgery
Ancillary Maneuvers Used to Facilitate Colonoscope Advancement
Using ancillary maneuvers during colonoscopy (position change, pressure application, increase stiffness, etc...) to facilitate colonoscope advancement through the colon.
Measured: During Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start6 Jan 2025
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asad Ur Rahman, Fnu, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776913
- Sponsor's protocol ID
- 24-891
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2025
- Last updated
- 20 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Ahmad AI, Ansari Z, Jamal Al-Din T, Nicolas MA, Restrepo D, Almomani A, Zahid E, Gonzalez A, Klein D, Jimenez B, Castro F, Ur Rahman A. Pediatric vs Adult Colonoscopes' Effectiveness in Obese Patients: The PACE Randomized Clinical Trial. Am J Gastroenterol. 2026 Apr 20. doi: 10.14309/ajg.0000000000004027. Online ahead of print.
PubMed 42007569
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Adult to Pediatric Colonoscope in Obese Patients.
- ClinicalTrials.gov ID
- NCT06776913
- Acronym / sponsor ID
- 24-891
- Keywords
- obesity, Screening Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Cleveland Clinic FloridaUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Posted 20 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test which colonoscope works best in people who are above a certain body mass index. Currently, both pediatric and adult colonoscopes are accepted as standard treatments in colonoscopies. Endoscopist pick which one to use based on personal preference and what is available.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult Colonoscope | Active comparator | Device: ColonoscopyStandard colonoscopy performed with adult colonoscope. |
| Pediatric Colonoscope | Active comparator | Device: ColonoscopyStandard colonoscopy performed with pediatric colonoscope. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- BMI greater than 30
- Screening and surveillance colonoscopy
Key exclusion criteria (6 listed)
- Colon surgery
- Therapeutic colonoscopy
- Inflammatory bowel disease
- Terminated procedure due to stool burden, stenosis, or obstructive mass.
- Colonoscopy for anemia
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 |
|---|---|---|
| ColonoscopyStandard Colonoscopy with photo documentation and the recording of procedure timing. | Device | Adult Colonoscope, Pediatric Colonoscope |
Primary outcome
Composite of Reaching the Cecum in Less Than 10 Minutes Without Changing the Scope Type.
Time frame: During Surgery, up to 10 minutes
The outcome aims to measure the difficult colonoscope which is defined as either not reaching the cecum, needing more than 10 minutes, or the need to exchange to a different device.
5 secondary outcomes
Number of Participants With Successful Advancement of Colonoscope to the Cecum
Time frame: During Surgery
Number of Participants With Successful Advancement of Colonoscope to the Terminal Ileum
Time frame: During Surgery
Time Taken to Advance the Colonoscope From the Rectum to the Cecum.
Time frame: During Surgery
Time Taken to Withdraw Colonoscope From Cecum to Rectum (Withdrawal Time)
Time frame: During Surgery
Ancillary Maneuvers Used to Facilitate Colonoscope Advancement
Time frame: During Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42007569Ahmad AI, Ansari Z, Jamal Al-Din T, Nicolas MA, Restrepo D, Almomani A, Zahid E, Gonzalez A, Klein D, Jimenez B, Castro F, Ur Rahman A. Pediatric vs Adult Colonoscopes' Effectiveness in Obese Patients: The PACE Randomized Clinical Trial. Am J Gastroenterol. 2026 Apr 20. doi: 10.14309/ajg.0000000000004027. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy in people with Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2) and Screening Colonoscopy, run by Cleveland Clinic Florida 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 2 inclusion and 6 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 20 Mar 2026. 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?
Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite of Reaching the Cecum in Less Than 10 Minutes Without Changing the Scope Type. (time frame: During Surgery, up to 10 minutes). 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 NCT06776913, which also lists 1 linked publication.
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 20 Mar 2026.