Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04773795
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2021-02-21
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:
Nitinotes Surgical Ltd
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:
2024-02
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 kgm2
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 months
Remote follow up by Phone 3 5 7 9 and 11 months
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 baseline2 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 months
Remote follow up by Phone 3 5 7 9 and 11 months
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 baseline2 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:
None
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?:
None