CompletedNot Applicable

Novel Motorized Spiral Enteroscopy Vs Single Balloon Enteroscopy In Patients With Small Bowel Disorders- A RCT

India46 participantsStarted 2022-09-20

Plain-language summary

STUDY OBJECTIVES: 1. Primary objective: Rate of total enteroscopy (TER) by means of NMSE or SBE with: Complete antegrade approach or combined antegrade and retrograde approach 2. Secondary objective: 1. Technical success of anterograde and retrograde approach 2. Procedural time (minutes) 3. Depth of maximum insertion (cm) 4. Diagnostic yield 5. Therapeutic success 6. Adverse events

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with small bowel disease with an indication for total enteroscopy with indeterminate imaging findings (as defined above)
. Age \> 18 years
. Patients willing to give written consent

Exclusion criteria

. Positive imaging findings (as defined)
. Age \< 18 years.
. Contraindications for endoscopy due to comorbidities
. Unable to provide written informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of total enteroscopy (TER)

Timeframe: 1 year

Trial details

NCT IDNCT05548140

SponsorAsian Institute of Gastroenterology, India

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-15

View on ClinicalTrials.gov More Small Bowel Disease trials