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The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study

NCT03990207 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-05

No results posted yet for this study

Summary

To evaluate safety and efficacy

Conditions

  • Small Bowel Disease

Interventions

DEVICE

PowerSpiral Enteroscopy System

Motorized spiral enteroscopy system

Sponsors & Collaborators

  • Baylor Research Institute

    collaborator OTHER

  • University of Massachusetts, Worcester

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • AdventHealth

    collaborator OTHER

  • Rhode Island Hospital

    collaborator OTHER

  • Olympus Corporation of the Americas

    lead INDUSTRY

Principal Investigators

  • Daniel DeMarco, MD · Baylor Health Care System

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-06-30
Completion
2023-10-31
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 NCT03990207 on ClinicalTrials.gov