Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-29 @ 6:35 PM
Study NCT ID:
NCT04773795
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2021-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods
Sponsor:
Nitinotes Surgical Ltd.
Organization:
Study Overview
Official Title:
Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multicenter, prospective, single-arm, open-label, controlled clinical trial aimed to evaluate the safety and effectiveness of the EndoZip system procedure, coupled with lifestyle modifications, for weight reduction in obese patients with BMI of 30-40 kg/m2.
Detailed Description:
study will include up to 45 (10-20 patients per site), ages of 21 -70 of obese patients who failed to reduce weight with non-surgical weight-loss methods.
The duration for each participant will be 12 months and will include the following follow up visits and procedures:
* Office visits: screening, 1 week, and 1, 2, 4, 6, 8, 10, and 12 month(s)
* Remote follow up (by Phone): 3, 5, 7, 9, and 11 month(s)
* Endoscopy procedure: baseline, 2 and 6 months post EndoZip procedure
* Motility evaluation by Gastric Emptying Breath Test (GEBT): baseline, 6 months
* Physical examination, vital signs, waist circumference and BMI: baseline, 1 week, 1, 2, 4, 6, 8, 10 and 12 months
* Blood tests: baseline,2, 6 and 12 months
* IWQOL-Lite: baseline, 2, 6 and 12 months
* Psychological health questionnaire-9 (PHQ-9) :baseline
* Sleep Apnea (only for the relevant population): baseline 2, 6 and 12 months
The patient will required to follow a specific diet and to have a physical activity during the study period ( 12 month).
The duration for each participant will be 12 months and will include the following follow up visits and procedures:
* Office visits: screening, 1 week, and 1, 2, 4, 6, 8, 10, and 12 month(s)
* Remote follow up (by Phone): 3, 5, 7, 9, and 11 month(s)
* Endoscopy procedure: baseline, 2 and 6 months post EndoZip procedure
* Motility evaluation by Gastric Emptying Breath Test (GEBT): baseline, 6 months
* Physical examination, vital signs, waist circumference and BMI: baseline, 1 week, 1, 2, 4, 6, 8, 10 and 12 months
* Blood tests: baseline,2, 6 and 12 months
* IWQOL-Lite: baseline, 2, 6 and 12 months
* Psychological health questionnaire-9 (PHQ-9) :baseline
* Sleep Apnea (only for the relevant population): baseline 2, 6 and 12 months
The patient will required to follow a specific diet and to have a physical activity during the study period ( 12 month).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: