Jejunostomy; ComplicationsNCT06095804
Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure
A study testing Percutaneous Ultrasound Jejunostomy in people with Jejunostomy; Complications and Enteral and Supplement Feeds Adverse Reaction, run by CoapTech at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Jejunostomy; Complications, Enteral and Supplement Feeds Adverse Reaction, Safety Issues
- What is being tested?
- Percutaneous Ultrasound Jejunostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
Bruce Greenwald, MD, 410-328-8731, Bgreenwa@som.umaryland.edu
Bruce Greenwald, MD
About this study
Official title: 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.
Read the 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).
- Being tested
- Percutaneous Ultrasound Jejunostomy
- Keywords
- Jejunostomy, Enteral Feeding, Long-term Enteral Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Ultrasound JejunostomyDevice
Placement of a jejunostomy tube using the PUMA-J System
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Ultrasound Jejunostomy | Experimental | Placement of a longterm jejunostomy tube using the PUMA-J System Receives: Device: Percutaneous Ultrasound Jejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
Rate of procedural success in completing jejunostomy tube placement using the PUMA-J System
Measured: Procedure timeframe
Secondary outcomes (5)
Procedural Aborts
Description of occurrences of procedure abort
Measured: Procedure timeframe
Device Related Serious Adverse Events
Rate of Device Related Adverse Events following Jejunostomy procedure
Measured: 48 hours of procedure performance
Adverse Events
Rate of all Adverse Events following Jejunostomy procedure
Measured: 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
Measured: Procedure timeframe
Requirement for salvage surgery due to complication of the procedure
Description of occurrences of salvage surgery performed due to complication of procedure
Measured: 48 hours of procedure performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jejunostomy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoapTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095804
- Sponsor's protocol ID
- HP-00107625
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Pilot Study to Evaluate the Feasibility of the Percutaneous Ultrasound Jejunostomy (PUJ)
- ClinicalTrials.gov ID
- NCT06095804
- Acronym / sponsor ID
- HP-00107625
- Keywords
- Jejunostomy, Enteral Feeding, Long-term Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- CoapTechIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Ultrasound Jejunostomy | Experimental | Device: Percutaneous Ultrasound JejunostomyPlacement of a longterm jejunostomy tube using the PUMA-J System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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):
- Patient determined to be an appropriate candidate for percutaneous jejunostomy by the study team
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Ultrasound JejunostomyPlacement of a jejunostomy tube using the PUMA-J System | Device | Percutaneous Ultrasound Jejunostomy |
Primary outcome
Procedural Success
Time frame: Procedure timeframe
Rate of procedural success in completing jejunostomy tube placement using the PUMA-J System
5 secondary outcomes
Procedural Aborts
Time frame: Procedure timeframe
Device Related Serious Adverse Events
Time frame: 48 hours of procedure performance
Adverse Events
Time frame: 48 hours of procedure performance
Rate of inadvertent puncture of vital organs
Time frame: Procedure timeframe
Requirement for salvage surgery due to complication of the procedure
Time frame: 48 hours of procedure performance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Ultrasound Jejunostomy in people with Jejunostomy; Complications and Enteral and Supplement Feeds Adverse Reaction, run by CoapTech at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials (443 574 6934, regulatory@coaptech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success (time frame: Procedure timeframe). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.