NCT06095804

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

October 18, 2023

Last Update Submit

October 18, 2023

Conditions

Jejunostomy; ComplicationsEnteral and Supplement Feeds Adverse ReactionSafety Issues

Keywords

JejunostomyEnteral FeedingLong-term Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • Procedural Success

    Rate of procedural success in completing jejunostomy tube placement using the PUMA-J System

    Procedure timeframe

Secondary Outcomes (5)

  • Procedural Aborts

    Procedure timeframe

  • Device Related Serious Adverse Events

    48 hours of procedure performance

  • Adverse Events

    48 hours of procedure performance

  • Rate of inadvertent puncture of vital organs

    Procedure timeframe

  • Requirement for salvage surgery due to complication of the procedure

    48 hours of procedure performance

Study Arms (1)

Percutaneous Ultrasound Jejunostomy

EXPERIMENTAL

Placement of a longterm jejunostomy tube using the PUMA-J System

Device: Percutaneous Ultrasound Jejunostomy

Interventions

Percutaneous Ultrasound JejunostomyDEVICE

Placement of a jejunostomy tube using the PUMA-J System

Percutaneous Ultrasound Jejunostomy

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent must be obtained before any study-specific assessment is performed
  • Male or female \> 21 years of age
  • Estimated tract length (skin to anterior abdominal wall) \<= 4.5cm on prior imaging
  • Indication for percutaneous jejunostomy tube placement determined to be present by the primary clinical care team (examples below):
  • High aspiration risk
  • Malnourished- chronically ill and/or neurologically impaired requiring jejunal feeding for \>30 Days.
  • Neoplasia (stomach and esophagus)
  • Gastric and duodenal obstruction
  • Gastrointestinal dysmotility (gastroparesis)
  • Altered anatomy (gastric-esophageal surgeries)
  • Other indication deemed to be appropriate by the study team
  • Patient determined to be an appropriate candidate for percutaneous jejunostomy by the study team
  • Women of childbearing potential must have negative serum or urine pregnancy test during the current hospitalization

You may not qualify if:

  • Temperature ≥ 38 C
  • Systolic BP \< 90 or \> 180 mmHg
  • Heart Rate \< 50 or \> 120
  • Presence of a contraindication to being in proximity to a magnet (e.g. pacemaker)
  • History of prior major abdominal surgery
  • Patients with HgB \< 7g/dL, or fluid resuscitated within 48hrs prior, or history of life-threatening gastrointestinal bleeding within 1 month
  • Pregnant or nursing (lactating) women
  • Involvement in other investigational trials within 30 days prior to screening
  • Absolute contraindications:
  • Sepsis
  • Severe ascites
  • Peritonitis
  • Coagulopathy (international normalized ratio (INR) greater than 1.5 or a platelet count of less than 50,000/uL)
  • Abdominal wall infection at the site of planned tube insertion
  • Interposed organs as determined by imaging
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Central Study Contacts

Clinical Trials

CONTACT

443 574 6934regulatory@coaptech.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 23, 2023

Study Start

December 1, 2023

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)