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Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure

NCT06095804 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the feasibility and performance of the Percutaneous Ultrasound Jejunostomy (PUJ) procedure that utilizes a novel device (PUMA-J System) in conjunction with widely available ultrasound technology and endoscopic guidance.

The procedure will be performed in up to 10 eligible subjects. Patients will be followed for 2 days following performance of PUJ to assess for potential complications.

Conditions

  • Jejunostomy; Complications
  • Enteral and Supplement Feeds Adverse Reaction
  • Safety Issues

Interventions

DEVICE

Percutaneous Ultrasound Jejunostomy

Placement of a jejunostomy tube using the PUMA-J System

Sponsors & Collaborators

  • University of Maryland, Baltimore

    collaborator OTHER

  • CoapTech

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-06-01
Completion
2025-07-01
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 NCT06095804 on ClinicalTrials.gov