Safety, feasibility and weight loss after transoral gastroplasty: First human multicenter study.
OBJECTIVE
To evaluate the safety and feasibility in human subjects of a new transoral restrictive procedure for the treatment of obesity.


METHODS
The protocol was approved by the institutional review boards (IRBs) of both centers involved, and all patients gave informed consent. Patients met established inclusion criteria for bariatric surgery. The TOGa system (Satiety Inc., Palo Alto, CA), a set of transoral endoscopically guided staplers, was used to create a stapled restrictive pouch along the lesser curve of the stomach. Patients were hospitalized overnight for observation and underwent barium upper gastrointestinal (UGI) the next morning. Post procedure, all patients were placed on a liquid diet for 1 month and asked to begin an exercise program. Follow-up was carried out at 1 week and 1, 3, 4, 5, and 6 months.


RESULTS
Twenty one patients were enrolled [17 female, age 43.7 (22-57) years, BMI 43.3 (35-53) kg/m(2)]. Device introduction was completed safely in all patients. There were no serious adverse events (AEs). The most commonly reported procedure or device related adverse events were vomiting, pain, nausea, and transient dysphagia. At 6 month endoscopy, all patients had persistent full or partial stapled sleeves. Gaps in the staple line were evident in 13 patients. Patients lost an average 17.6 pounds at 1 month, 24.5 pounds at three months, and 26.5 pounds at 6 months post-treatment [excess weight loss (EWL) of 16.2%, 22.6%, and 24.4%, respectively].


CONCLUSIONS
There is great interest in new procedures for morbid obesity that could offer lower morbidity than current options. Early experience with the TOGa procedure indicates that this transoral approach may be safe and feasible. Further experience with the device and technique should improve anatomic and functional outcomes in the future. Additional studies are underway.
Devière
J
J
Department of Gastroenterology and Hepatopancreatology, ULB, Hôpital Erasme, Route de Lennik 808, B-1070, Brussels, Belgium. jdeviere@ulb.ac.be
Ojeda Valdes
G
G
Cuevas Herrera
L
L
Closset
J
J
Le Moine
O
O
Eisendrath
P
P
Moreno
C
C
Dugardeyn
S
S
Barea
M
M
de la Torre
R
R
Edmundowicz
S
S
Scott
S
S
D000328:Adult; D015992:Body Mass Index; D004724:Endoscopy / Q000009:adverse effects / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000379:methods*; D005773:Gastroscopy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D009767:Obesity, Morbid / Q000175:diagnosis / Q000601:surgery*; D011183:Postoperative Complications / Q000503:physiopathology; D011446:Prospective Studies; D011788:Quality of Life; D018570:Risk Assessment; D017751:Safety Management; D016037:Single-Blind Method; D016896:Treatment Outcome; D015431:Weight Loss