Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorNitinotes Surgical Ltd.
About this trial
evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 21-65
BMI ≥ 30 and ≤50 kg/m².
Willingness to comply with the substantial behavioral modifications and dietary restrictions as required by the procedure.
History of failure with non-surgical weight-loss methods.
Disqualifiers
History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
Prior open or laparoscopic bariatric surgery.
Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
EndoZip System
DeviceThe EndoZip System is a single-use automated suturing device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach.
OverStitch Endoscopic Suturing System (ESG)
DeviceThe OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach.
Treatment groups
184 Participants
are divided into 2 treatment groupsGroup A: EndoZip SystemExperimental treatment 1 intervention
Group B: OverStitch Endoscopic Suturing SystemActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean percent of total body weight loss (%TBWL) after 12 months in Group A patients versus Group B.
Time frame
12 months2
Percentage of patients in Group A with a reduction in %TBWL of at least 5% at 12 months
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov