Early Feasibility Study: Assessment of Self-Forming Magnetic Anastomosis Device and Delivery System (SFM) in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post SG (SNAP-PS), or Used to Create a Jejuno-Jejunal (J-J) Anastomosis — GIW-J-J

Obesity, Morbid Clinical Trial

Official title:
Single-Center, Two- Arm Study to Evaluate the Safety and Device Functionality of the SFM Anastomosis Device and Delivery System, When Used to Create a Duodenal-Ileal Anastomosis to Revise a Post SG (SNAP-PS), or Used to Create a Jejuno-Jejunal (J-J) Anastomosis of a Roux-en-Y

Status Recruiting

Clinical Trial Summary

The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis with patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure). Additionally, the study is designed to evaluate the potential of the SFM Anastomosis System to create a Jejuno-jejunostomy in Roux-en-Y gastric bypass procedures.

Clinical Trial Description

This is a two-arm, single-center, early feasibility study to evaluate the use of the SFM Anastomosis System for creation of a duodenal-ileal (D-I) anastomosis in participants who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort) defined to be failure to achieve a minimum 50% EWL post sleeve gastrectomy or a patient undergoing a Roux-en-Y gastric bypass the SFM will be used to create the jejuno-jejunostomy. Adult male and female subjects between the ages of 18 and 65 years-old who are candidates for the primary or revisional surgery will be considered for participation. Patients appearing to meet basic eligibility criteria and who sign the study specific consent form will be screened for enrollment into this study and will be assessed by a multidisciplinary research team with pre-procedure nutritional and medical evaluation (including psychological and behavioral evaluation by an internist/bariatrician). Subjects meeting the inclusion and exclusion criteria and enrolled into the study will undergo a procedure in which the SFM device and delivery systems with create anastomoses between the duodenum and ileum or jejunum to jejunum. ;

Study Design

Related Conditions & MeSH terms

Obesity, Morbid

Clinical Trial Details

NCT number	NCT06200896
Study type	Interventional
Source	GI Windows, Inc.
Contact	Gabriela Paz Fuentealba Ortiz
Phone	+56 9 42306256
Email	gabriela.pazfo@gmail.com
Status	Recruiting
Phase	N/A
Start date	December 12, 2023
Completion date	April 12, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.