NCT05228379

Brief Summary

Examination of the small bowel has been considered a challenge for several anatomical (i.e. distance from external orifices, length) and physiological (i.e. active peristalsis) reasons. Conventional techniques of endoscopy are limited by length while radiologic examinations, such as barium studies, are insensitive for evaluating small bowel pathology. An ingestible miniature camera device capable of obtaining images of the whole small intestine was developed due to a need for the exploration of this "final frontier". The purpose of this article is to review and share our institution's results using small bowel capsule endoscopy, with special reference to the existing literature.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,157

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

8.5 years

First QC Date

January 3, 2022

Last Update Submit

January 27, 2022

Conditions

Keywords

capsule endoscopysmall bowel

Outcome Measures

Primary Outcomes (1)

  • Indications for doing capsule endoscopy procedure

    The study will help find the various indications for doing capsule endoscopy for small bowel diseases.

    8-9 years

Secondary Outcomes (2)

  • Findings visualized on capsule endoscopy.

    8-9 years

  • Diagnostic yield of capsule endoscopy

    8-9 years

Interventions

A wireless capsule is ingested by the patient. It moves passively along with the peristaltic movements to capture images of the small intestine. The images are processed and recorded by data recorder worn on a belt. The recorded images are downloaded and analyzed by the computer software.

Eligibility Criteria

Age6 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study includes patients who underwent capsule endoscopy from Jan 2013 till 30 June, 2021.

You may qualify if:

  • All patients who underwent capsule endoscopy in AIG Hospitals Hyderbad till 30 June, 2021 will be enrolled in the study.

You may not qualify if:

  • Patients in whom capsule was unable to reach caecum.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Goenka MK, Majumder S, Kumar S, Sethy PK, Goenka U. Single center experience of capsule endoscopy in patients with obscure gastrointestinal bleeding. World J Gastroenterol. 2011 Feb 14;17(6):774-8. doi: 10.3748/wjg.v17.i6.774.

  • Yung DE, Robertson AR, Davie M, Sidhu R, McAlindon M, Rahman I, Patel P, Sinha L, Mason S, Brzeszczynska J, Douglas S, Plevris JN, Koulaouzidis A. Double-headed small-bowel capsule endoscopy: Real-world experience from a multi-centre British study. Dig Liver Dis. 2021 Apr;53(4):461-466. doi: 10.1016/j.dld.2021.01.017. Epub 2021 Feb 8.

  • Flemming J, Cameron S. Small bowel capsule endoscopy: Indications, results, and clinical benefit in a University environment. Medicine (Baltimore). 2018 Apr;97(14):e0148. doi: 10.1097/MD.0000000000010148.

  • Kav T, Bayraktar Y. Five years' experience with capsule endoscopy in a single center. World J Gastroenterol. 2009 Apr 28;15(16):1934-42. doi: 10.3748/wjg.15.1934.

Study Officials

  • Neeraj Singla, MBBS, MD, DM

    Consultant Gastroenterologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2022

First Posted

February 8, 2022

Study Start

January 1, 2013

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

February 8, 2022

Record last verified: 2022-01