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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for placing feeding tubes using ultrasound and endoscopic guidance. The researchers aim to determine if this method, called Percutaneous Ultrasound Jejunostomy, is safe and effective for individuals requiring long-term feeding support. Suitable candidates may have conditions such as difficulty swallowing, risk of aspiration, or stomach blockages, and need a feeding tube for more than 30 days. Researchers will monitor participants for complications for two days following the procedure. As an unphased trial, this study allows participants to contribute to innovative medical research that could enhance future care for those needing long-term feeding assistance.

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 prior data suggests that the Percutaneous Ultrasound Jejunostomy procedure is safe?

Research shows that the Percutaneous Ultrasound Jejunostomy (PUJ) procedure is generally safe and effective. Studies have found it has a high success rate with a low risk of serious complications. Most issues are minor, such as some pain or a slight infection. For instance, one study reported no major complications, and patients gained weight after the tube was placed. This suggests the procedure is well-tolerated. Overall, the PUJ procedure appears to be a safe option for those needing a feeding tube. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Percutaneous Ultrasound Jejunostomy (PUJ) is unique because it uses a minimally invasive approach to place a feeding tube directly into the jejunum, which is a part of the small intestine. Unlike traditional surgical options that often require more invasive procedures, the PUJ uses the PUMA-J System to perform the task with precision and reduced recovery time. Researchers are excited about this approach because it could offer patients a safer, quicker, and less painful alternative to current methods, potentially improving overall care and reducing hospital stays.

What evidence suggests that the Percutaneous Ultrasound Jejunostomy procedure is effective for feeding tube access creation?

Research has shown that using ultrasound to guide feeding tube placements can be effective, especially when other methods are not viable. One study found ultrasound successful in 27 out of 238 cases (11%) where other methods failed. Jejunostomy tubes, which deliver nutrition directly to the small intestine, are typically placed successfully using various techniques. Both keyhole surgery and imaging-guided methods have success rates exceeding 95%. This trial will specifically evaluate the Percutaneous Ultrasound Jejunostomy procedure, suggesting that ultrasound for placing jejunostomy tubes could also be a reliable method. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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

Pacemakers or other electronically active implantable devices

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/percutaneous-ultrasound-jejunostomy-procedure-for-feeding-tube-access-creation-88c4c

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

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044319310449

Jejunostomy Tube Insertion for Enteral Nutrition Technical success rates were 95% (110 of 115) for laparoscopic and 97% (103 of 106) for radiologic jejunostomy tube insertion (P = .72). Major procedural ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9010104/

Direct percutaneous endoscopic jejunostomy (DPEJ) and ... Conclusions DPEJ and PEG-J are safe and effective procedures placed with high fidelity with comparable outcomes. DPEJ was associated with fewer ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05966311

Pediatric Percutaneous Ultrasound Gastrostomy Technique The research will measure if the device works well to safely aid doctors placing gastrostomy feeding tubes in children. The PUMA-G Pediatric System is an ...

5. giejournal.org giejournal.org/article/S0016-5107(20)35115-4/fulltext

Prognostic outcomes after direct percutaneous endoscopic ... Successful placement rates were 93.9% and 97.1% for DPEJ and PEG, respectively. There was no significant difference in procedure-related adverse ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3275411/

Current considerations in direct percutaneous endoscopic ... No major complications occurred, and all patients gained weight after tube placement. The authors believed that DPEJ placement appeared to be a safe and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044312009062

Percutaneous Jejunostomy: Repeat Access at the Healed ... Successful tube placement was achieved in 26 of 28 attempts (92%). The mean time between removal of the original surgical jejunostomy and percutaneous placement ...

8. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/jpen.2615

A clinical consensus paper on jejunal tube feeding in children A recent systematic review assessing safety and efficacy outcomes of Roux-en-Y jejunostomy in children reported complications in about 50%, ...