Percutaneous Ultrasound Jejunostomy Procedure for Feeding Tube Access Creation

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CoapTech

Disqualifiers: Sepsis, Severe ascites, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Percutaneous Ultrasound Jejunostomy?

Research shows that using ultrasound guidance for placing feeding tubes, like in Percutaneous Ultrasound Jejunostomy, is effective and safe, especially in patients who have had previous surgical procedures or when other methods are not possible. ^{1 2 3 4 5}

Is the Percutaneous Ultrasound Jejunostomy Procedure generally safe for humans?

The procedure is generally considered safe with a high success rate and low risk of serious complications, though minor issues like pain, infection, and tube-related problems can occur. ^{1 6 7 8 9}

How is the percutaneous ultrasound jejunostomy procedure unique compared to other treatments for feeding tube access?

The percutaneous ultrasound jejunostomy procedure is unique because it uses ultrasound guidance to place a feeding tube directly into the small intestine, which can be safer and more effective for patients who have had previous surgical jejunostomies or cannot undergo endoscopic procedures. This method offers a minimally invasive alternative to traditional surgical approaches, potentially reducing recovery time and complications. ^{1 2 3 5 10}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 21 needing a jejunostomy tube, with specific conditions like high aspiration risk or chronic malnutrition. Candidates must have an appropriate tract length and not be pregnant. Exclusions include severe vital sign abnormalities, major abdominal surgery history, certain blood conditions, and contraindications to magnets or endoscopy.

Inclusion Criteria

High aspiration risk

I have been on tube feeding for over 30 days due to chronic illness or neurological issues.

My care team has decided I need a tube placed in my intestine for feeding.

Exclusion Criteria

Coagulopathy (international normalized ratio (INR) greater than 1.5 or a platelet count of less than 50,000/uL)

Interposed organs as determined by imaging

I have no health conditions that prevent endoscopy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Placement of a long-term jejunostomy tube using the PUMA-J System

Procedure timeframe

Immediate Follow-up

Participants are monitored for complications and adverse events following the procedure

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Percutaneous Ultrasound Jejunostomy

Trial Overview The study tests the safety and effectiveness of a new procedure called Percutaneous Ultrasound Jejunostomy (PUJ) using the PUMA-J System alongside ultrasound technology. Up to 10 patients will undergo PUJ and be monitored for two days post-procedure for any complications.

Participant Groups

Group I: Percutaneous Ultrasound Jejunostomy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

CoapTech

Lead Sponsor

Trials

4

Recruited

160+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

University of Maryland Medical Center

Collaborator

Trials

4

Recruited

850+

Findings from Research

Ultrasound guidance was successfully used in 27 out of 238 feeding tube placements (11%) when nasogastric tube placement was not possible due to upper gastrointestinal obstruction.

The use of ultrasound allowed for rapid and safe puncture of the stomach in 26 patients, with no complications reported, demonstrating its efficacy as an alternative method for feeding tube placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound guidance in percutaneous gastrostomy and gastrojejunostomy. Pugash, RA., Brady, AP., Isaacson, S.[2019]

Ultrasound-guided placement of gastric feeding tubes was successfully performed in 34 out of 38 patients with upper gastrointestinal obstruction, demonstrating its feasibility as a method when endoscopic placement is not possible.

The procedure was safe, with no major complications reported, and it helped stabilize body weight and nutritional parameters in patients over a mean follow-up of 4 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous sonographic gastrostomy: method, indications, and problems. Bleck, JS., Reiss, B., Gebel, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Percutaneous jejunostomy: repeat access at the healed site of prior surgical jejunostomy with US and fluoroscopic guidance. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Percutaneous alternatives in nutritional support: a radiologic perspective. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

A simple technique for insertion of PEJ via PEG. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Ultrasound guidance in percutaneous gastrostomy and gastrojejunostomy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Percutaneous sonographic gastrostomy: method, indications, and problems. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events associated with percutaneous enteral access. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Percutaneous Endoscopic Jejunostomy Placement Compared With Surgical and Radiologic Jejunostomy Placement: A Nationwide Inpatient Assessment. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Fluoroscopically guided percutaneous jejunostomy: outcomes in 25 consecutive patients. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Direct percutaneous jejunostomy--an underutilized interventional technique? [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Technical developments and instrumentation: percutaneous transhepatic feeding jejunostomy. [2019]