Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure

CoapTech

Status

Not yet enrolling

Conditions

Enteral and Supplement Feeds Adverse Reaction

Safety Issues

Jejunostomy; Complications

Treatments

Device: Percutaneous Ultrasound Jejunostomy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06095804

HP-00107625

Details and patient eligibility

About

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.

Full 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).

Enrollment

10 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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.