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Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures

NCT06111131 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2024-04-19

No results posted yet for this study

Summary

Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube.

Conditions

  • Small Bowel Disease

Interventions

DEVICE

Enteroscopy

A procedure that uses a specially equipped endoscope to examine the small intestine lining. An enteroscopy uses an endoscope, a tube with a light and camera on the end and the endoscope, in the case of this study, is equipped with a single balloon overtube to advance the scope deeper into the small intestine, to reach the middle third of the small bowel.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Aspero Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-03-15
Completion
2025-05-15
FDA Device
Yes

Countries

  • United States

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 NCT06111131 on ClinicalTrials.gov