MedTrace Logo

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

NCT05548140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-03-27

No results posted yet for this study

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

Conditions

  • Small Bowel Disease

Interventions

DEVICE

Novel Motorized Spiral Enteroscopy

This study involves performance of spiral enteroscopy in one arm and single balloon enteroscopy in the other arm in patients who satisfy inclusion criteria

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Dr Hardik Rughwani, MBBS, MD, DM · AIG Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2022-12-15
Completion
2022-12-15

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05548140 on ClinicalTrials.gov