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NCT05363930

The MOTOR-CD Trial

Completed NA Last updated 14 September 2023
What this trial tests

NA trial testing Novel motorized spiral enteroscopy in Crohn's Disease in 128 participants. Completed in 30 September 2022.

Timeline
7 May 2022
Primary endpoint
30 September 2022
30 September 2022

Quick facts

Lead sponsorAsian Institute of Gastroenterology, India
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment128
Start date7 May 2022
Primary completion30 September 2022
Estimated completion30 September 2022
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Asian Institute of Gastroenterology, India

Who can join

Adults 18 to 65, any sex, with Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Both single-balloon enteroscopy (SBE) and novel motorized spiral enteroscopy (NMSE) are effective techniques for small bowel endoscopy in suspected Crohn's disease (CD). Small bowel endoscopy is indicated for confirming diagnosis when CD is suspected based on clinical features along with cross-sectional small bowel imaging (computed tomography enterography/enteroclysis: CTE or magnetic resonance enterography/enteroclysis: MRE) or capsule endoscopy (CE). It not only helps in diagnosing CD, but it also helps in excluding CD, diagnosing alternate conditions and taking a surgical decision if a tight stricture is found. The pilot study done by the investigators in 177 suspected CD patients (37.2% female, 7-75 years) undergoing total 201 device assisted enteroscopy (DAE) showed that NMSE scores over SBE with regards to small bowel evaluation with complete small bowel coverage and shorter procedure time. The investigators aim to validate this findings by comparing technical performance and diagnostic yield between NMSE (Olympus Medical, Tokyo, Japan) and SBE (Olympus Medical Systems Corporation, Tokyo, Japan) for small bowel evaluation. Additionally the investigators plan to compare depth of insertion, total enteroscopy rates, procedure time, adverse event rates between the two modalities. To date, no study has compared both modalities in suspected Crohn's disease (CD) requiring small bowel evaluation in a randomized manner. Hence the investigators intend to perform a randomized controlled study based on these preliminary finding with appropriate matching and parallel study design in larger numbers.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Technical performance and diagnostic yield of motorised spiral enteroscopy compared with single-balloon enteroscopy in suspected Crohn's disease: a randomised controlled, open-label study (the MOTOR-CD trial).
    Pal P, Ramchandani M, Banerjee R, Viswakarma P, et al · · 2023 · cited 11× · PMID 37197904 · DOI 10.1136/gutjnl-2023-329885
  2. 63rd Annual Conference of the Indian Society of Gastroenterology, ISGCON 2022-January 5th - 8th, 2023 in Jaipur.
    · 2023 · PMID 36512172 · DOI 10.1007/s12664-022-01305-9

Verify or expand the search:

Other recruiting trials for Crohn's Disease

Currently open trials in the same condition.

Other Asian Institute of Gastroenterology, India trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05363930.

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