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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Self Forming Magnets used to Create A Compression Anastomosis connecting the Duodenum to the ileal in Post Sleeve Gastrectomy Patients and Jejunum to jejunum in Roux-en-Y patients.
Clínica Colonial Hospital
Santiago, Santiago Province, Chile
Ability for physician to create a Magnet (SFM) Anastomosis
Ability to create the anastomosis with SFM without the need for open conversion or use of additional laparoscopic/endoscopic anastomoses devices (endoscopic/laparoscopic suture devices or staplers - except for closure of the laparoscopic enterotomy).
Time frame: 2 days
Safety of Creating a Magnet (SFM) Anastomosis
"Freedom from anastomosis adverse events" or "FFAAE" within 30 days including American College of Surgeons (ACS) Grade B/C anastomosis leak (requiring active therapeutic intervention/re-laparotomy), anastomotic bleeding, and small bowel obstruction. All adverse events will be documented.
Time frame: 30 days
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