Trial Outcomes & Findings for Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods (NCT NCT04773795)

Results Overview

Change in body total body weight loss (kg) from baseline to 12 months post EndoZip procedure

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

12 month

Results posted on

2025-08-13

Participant milestones
Measure	EndoZip System The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight. EndoZip System: The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.
Overall Study STARTED	48
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	3

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	EndoZip System n=45 Participants The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight. EndoZip System: The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.
Age, Continuous	44.13 years STANDARD_DEVIATION 8.76 • n=45 Participants
Sex: Female, Male Female	40 Participants n=45 Participants
Sex: Female, Male Male	5 Participants n=45 Participants

Timeframe: 12 month

Change in body total body weight loss (kg) from baseline to 12 months post EndoZip procedure

Outcome measures
Measure	EndoZip System n=45 Participants The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight. EndoZip System: The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.
Change in Body Total Body Weight Loss (kg) From Baseline to12 Months	13.2 kg Standard Error 1.5

Timeframe: 12 month

Percentage of patients with a reduction in %TBWL of at least 5% from baseline to 12 months.

Outcome measures
Measure	EndoZip System n=45 Participants The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight. EndoZip System: The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.
Percentage of Patients With a Reduction in %TBWL of at Least 5% From Baseline to 12 Months.	34 Participants

Serious events: 2 serious events

Other events: 2 other events

Deaths: 3 deaths

Serious adverse events
Measure	EndoZip System n=45 participants at risk The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight. EndoZip System: The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.
Surgical and medical procedures Bleeding next to the suture area	2.2% 1/45 • Number of events 1 • 1 year after the EndoZip procedure
Surgical and medical procedures Mild Gastric perforation	2.2% 1/45 • Number of events 1 • 1 year after the EndoZip procedure

Other adverse events
Measure	EndoZip System n=45 participants at risk The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight. EndoZip System: The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.
Surgical and medical procedures abdominal pain	2.2% 1/45 • Number of events 1 • 1 year after the EndoZip procedure
Surgical and medical procedures anemic	2.2% 1/45 • Number of events 1 • 1 year after the EndoZip procedure

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