Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-18
Brief Title:
Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure
Sponsor:
CoapTech
Organization:
CoapTech
Study Overview
Official Title:
A Single Center Pilot Study to Evaluate the Feasibility of the Percutaneous Ultrasound Jejunostomy PUJ
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None