StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight

The Roux-en-Y gastric bypass (RNYGB) is the most commonly performed bariatric procedure to
treat morbid obesity 1. Numerous studies have documented the effectiveness of RNYGB in
promoting excess weight loss (EWL) typically in the 65-80% range after 1.5 to 2 years 1.
Despite the favorable short-term outcomes of this bariatric surgical procedure, approximately
10-40% of patients do not achieve successful long-term weight loss 2. The weight regain
occurs typically within 2 to 7 years after RNYGB surgery and is associated primarily with
dilation of the gastric pouch or stoma 3, 4. Several open and laparoscopic bariatric revision
procedures have been used in an attempt to correct these dilations, but they all have been
associated with serious complications such as perforations, obstruction, staple line
disruption, blind loop syndrome, stoma ulcer, and incisional hernias 2, 5, 6. Because of this
high rate of morbidity associated with revisional gastric bypass surgery, less invasive
endoscopic procedures may become a preferred approach for weight regain after RNYGB 7, 8.

The StomaphyX delivery system with SerosaFuse fasteners consist of an ergonomic, flexible
fastener delivery device and sterile polypropylene fastener implants. The unit is provided
sterile and is a single use device. The polypropylene fasteners are proprietary and function
only with the StomaphyX device. The device uses vacuum to invaginate tissue through a port
into a chamber and fasten it using the H shaped polypropylene fasteners. The fastener
delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. They run
the length of the device, the pusher being a hollow tube that rides over the length of the
stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The
fastener is loaded by snapping it onto the stylet in the loading port of the handle. When
pushed by the operator, the stylet carries the fastener down the lumen which runs from the
proximal handle assembly to the distal tissue port where it will eventually be deployed into
the tissue. Durability of the SerosaFuse fasteners has been demonstrated during several
clinical studies utilizing the EsophyX device 9-12.

Reason for Conducting the Present Study: The goal of this study was to investigate the safety
and effectiveness of the StomaphyX device for revisional natural orifice surgery of the
gastric pouch and gastrojejunostomy anastomosis (stoma) in RNYGB patients to reduce regained
weight.

Inclusion Criteria:

- At least 18 years of age and less than 65 years of age

- BMI of at least 35 and no more than 40

- At least 2 years post-RNYGB surgery

- Initially achieved at least 60% EBL and a BMI 35 or less

- Regained at least 20% of pre-RNYGB excess weight at screening

- Stable weight or continued failure to lose weight for at least 3 months

- Enlarged gastric pouch (≥ 30 ml)

- Anatomy of upper GI judged suitable for revision using StomaphyX

- Completed successful nutritional screening

- Normal levels of vitamin D, iron/ferritin, calcium, and magnesium

- Absence of protein malnutrition confirmed by serum albumin > 3 g/dL

- Willing to cooperate with follow-up dietary recommendations and assessment tests

- Signed Informed Consent

Exclusion Criteria:

- Previous revisional bariatric surgery after RNYGB

- Esophageal stricture or any anatomic condition that precludes passage of the StomaphyX
device to the gastric pouch

- Diabetes type I

- Causal factors for weight regain other than gastric pouch enlargement

- Serious complications experienced during and/or after RNYGB such as leaks, fistula,
incisional hernia, ulcers, pulmonary embolism or deep venous thrombosis

- Pregnancy or plans of pregnancy in the next 12 months

- Immunosuppression

- ASA > 3

- Life expectancy less than one year

- An eating disorder, as defined by the Diagnostic and Statistical Manual of Mental
Disorders, 4th Ed, Washington DC, American Psychiatric Association, 2000

- Active substance abuse

- Plans of smoking cessation in the next 12 months

- Treatment with weight-loss prescription drug therapy within three months preceding the
screening

- Intention to use prescription drug therapy or the use of over-the-counter weight-loss
preparations during the current study

- Current participant in another weight-loss study or other clinical trial

- Inflammatory bowel disease

- Presence of ulceration at the gastrojejunostomy anastomosis

- Portal hypertension

- Coagulation disorders or chronic use of anticoagulants

- Any active medical condition that would preclude the patient from completing the study
or would result in an unreasonable risk to the patient