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Evaluation of the DiLumen Device During Colonoscopy

NCT03113578 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2017-12-02

No results posted yet for this study

Summary

This is an observational registry study collecting data on the clinical performance of the study device (DiLumen™ ) for its intended use. The primary objective is to evaluate functional outcomes of the DiLumen device in humans. The secondary objective is to evaluate safety characteristics of the DiLumen device.

Conditions

  • Colon Polyp

Interventions

DEVICE

DiLumen

The study device is placed over a compatible endoscope to facilitate endoscopic diagnosis and treatment of any large intestine pathology with the use of double balloons

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Lumendi, LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-26
Primary Completion
2017-09-27
Completion
2017-09-27
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03113578 on ClinicalTrials.gov