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A clinical trial to check if a new magnetic method is safe and works well for making an opening between the stomach and small intestine in people with a blocked food passage

A Combined Retrospective and Prospective, Single-Center, Single-Arm, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Magnetic Compression Anastomosis for Gastrojejunostomy in Patients with Benign or Malignant Gastric Outlet Obstruction - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093807
Enrollment
10
Registered
2025-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K312- Hourglass stricture and stenosis of stomach

Interventions

Intervention1: Magnetic Compression Anastomosis: Once,novel minimally invasive surgical technique for creating anastomoses using magnetic force Control Intervention1: NA: NA

Sponsors

Dr Sanjay Raput
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Age more than 18 years -Confirmed diagnosis of GOO (benign or malignant) -Deemed high-risk for surgery or declined surgical intervention -Retrospective cohort: Completed magnetic GJ procedure -Prospective cohort: Provided informed consent for magnet GJ

Exclusion criteria

Exclusion criteria: -Active gastrointestinal perforation or peritonitis -Ongoing or uncontrolled sepsis or systemic infection -Known or suspected gastrointestinal malignancy with distal metastases or obstruction precluding benefit from GJ -Severe coagulopathy (INR more than 1.5, Platelets less than 50,000/?L) uncorrectable prior to procedure -History of gastric or small bowel surgery that alters normal anatomy (e.g., Roux-en-Y, Billroth II) -Known allergy or hypersensitivity to materials used in the procedure (e.g., nickel in neodymium magnets) -Presence of implanted electronic or metallic medical devices that may be affected by magnetic fields (e.g., pacemakers, spinal cord stimulators) -Pregnancy or breastfeeding -Life expectancy more than 1 month (e.g., terminal stage malignancy) -Complete gastric outlet obstruction without possibility of endoscopic access -Electrolyte abnormalities (e.g., severe hyponatremia, hypokalemia) at time of procedure

Design outcomes

Primary

MeasureTime frame
Successful placement of magnets and formation of GJTimepoint: Day 1, day3 Day 7 day 10 day 55, 4 Month and 6 Months—

Secondary

MeasureTime frame
Relief from obstructive symptoms and resumption of oral intake Time to GJ formation Restenosis of new GJ site LAMS placement Average hospital stay Adverse Event Monitoring Timepoint: Day 1, day3 Day 7 day 10 day 55, 4 Month and 6 Months—

Countries

India

Contacts

Public ContactDr Sanjay Rajput

Ansh Clinic

isharajput2002@gmail.com9825021923

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026