Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure

A Single Center, Pilot Study to Evaluate the Feasibility of the Percutaneous Ultrasound Jejunostomy (PUJ)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Safety Issues; Jejunostomy; Complications; Enteral and Supplement Feeds Adverse Reaction
• Intervention / Treatment: Device: Percutaneous Ultrasound Jejunostomy

Detailed Description

Jejunostomy tubes (J-tubes) provide a path for nutrition delivery directly into the small intestinal lumen, bypassing the mouth, esophagus, and stomach for patients who have difficulty with proximal gut feeding. Many medical conditions may require J-tubes, including cancers, gastroparesis, and patients with high risk of aspiration.

A recent innovation by CoapTech addresses technical and procedural limitations of current jejunostomy tube placement methods by leveraging ultrasound for visualization and magnets for control of the jejunal loop. The Percutaneous Ultrasound Magnet Aligned (PUMA) System enables clinicians to affix jejunal loops superficially via magnetic coaptation and visualize the planned stomal tract using ultrasound. The purpose of this pilot clinical study is to test the feasibility of the PUMA-Jejunostomy (PUMA-J) System in adults requiring a jejunostomy tube.

This is a single-center, non-randomized, non-blinded feasibility study to evaluate the performance and safety of the PUJ procedure that utilizes a novel device (PUMA-J System).

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials; Phone Number: 443 574 6934; Email: regulatory@coaptech.com

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
      • Principal Investigator: Bruce Greenwald, MD
      • Contact: Bruce Greenwald, MD; Phone Number: 410-328-8731; Email: Bgreenwa@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
  • Abnormal upper gastrointestinal anatomy (e.g., partial or Total gastrectomy, Esophageal strictures)
  • Inflammatory, or infiltrative diseases of the small bowel and/or anterior abdominal wall.
  • Other standard general contraindications to endoscopy
  • Pacemakers or other electronically active implantable devices
  • Small bowel fistula
• Any other medical condition(s) that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous Ultrasound Jejunostomy; Placement of a longterm jejunostomy tube using the PUMA-J System	Device: Percutaneous Ultrasound Jejunostomy; Placement of a jejunostomy tube using the PUMA-J System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success	Rate of procedural success in completing jejunostomy tube placement using the PUMA-J System	Procedure timeframe

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Aborts	Description of occurrences of procedure abort	Procedure timeframe
Device Related Serious Adverse Events	Rate of Device Related Adverse Events following Jejunostomy procedure	48 hours of procedure performance
Adverse Events	Rate of all Adverse Events following Jejunostomy procedure	48 hours of procedure performance
Rate of inadvertent puncture of vital organs	Description of occurrences of inadvertent puncture of vital organs during performance of procedure	Procedure timeframe
Requirement for salvage surgery due to complication of the procedure	Description of occurrences of salvage surgery performed due to complication of procedure	48 hours of procedure performance

Collaborators and Investigators

• Sponsor: CoapTech
• Collaborators: University of Maryland, Baltimore; University of Maryland Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Enteral Feeding; Jejunostomy; Long-term Enteral Nutrition
• Other Study ID Numbers: HP-00107625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No