Endoscopy 2019; 51(04): S50-S51
DOI: 10.1055/s-0039-1681319
ESGE Days 2019 oral presentations
Friday, April 5, 2019 14:30 – 16:30: Bariatric Club B
Georg Thieme Verlag KG Stuttgart · New York

FIRST IN HUMAN RESULTS OF ENDOZIP, A NOVEL SUTURING BARIATRIC ENDOSCOPY PROCEDURE

G Lopez-Nava
1   Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital, Madrid, Spain
,
I Bautista-Castaño
1   Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital, Madrid, Spain
› Author Affiliations
Further Information

Publication History

Publication Date:
18 March 2019 (online)

Also available at
 

Aims:

Bariatric Endoscopic techniques (BET) have emerged to provide a treatment option for weight loss and associated comorbidities, in obese patients. A novel bariatric endoscopy gastroplasty, fully automated, more operator independent, minimally -invasive suturing system, called Endozip, enables to create multiple internal gastric walls segmentations by forming wall-wall full thickness suture of the stomach.

A prospective First in human open label single center study was carried out to assess Endozip procedure in terms of safety, feasibility and efficacy.

Methods:

13 patients (61.5% male; mean age 41 y, mean initial BMI 36.1 kg/m2 (range 30 – 39) underwent Endozip procedure between May and November 2018, in the Bariatric Endoscopy Unit of Madrid HM Sanchinarro University Hospital. Durability of the procedure was scheduled for endoscopic assessment at 1 and 6 months postprocedure. The primary outcome was the procedure safety and feasibility. The secondary outcomes were weight loss outcomes, measured by TBWL (total body weight loss), % TBWL and % excess weight loss (% EWL).

Results:

There were no intra-procedural nor early serious adverse events. All patients were discharged the day after the procedure. The average procedure time evolved from 120 min for the first 3 patients to 35 min for the last 3 patients). The average number of full thickness automatic sutures placed was 2.6 (range 2 – 3).

TBWL, % TBWL and % EWL were: at 1 month (n = 10): 9.3 kg, 8.9% and 33.4% respectively; at 3 month (n = 6): 11.8 kg, 11.5% and 46.1% respectively and at 6 month (n = 2): 20.9 kg, 20.9% and 95.3%. At 1 month endoscopic control showed that sutures were in place. The study is ongoing.

Conclusions:

Endozip procedure allows a minimally invasive automated suturing of the stomach. First in human results showed safety, feasibility and effectiveness in a short duration procedure. Some evolution in navigation and visibility will be key to include this procedure in the available BET.