Trials / Completed
CompletedNCT03472196
NitiNotes' EndoZip System for the Treatment of Obesity
First in Human Clinical Study to Assess the Safety and Preliminary Performance of NitiNotes' Endoluminal Gastroplasty System (EndoZip) for the Treatment of Obesity
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Nitinotes Surgical Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
This is first-in-man safety and performance feasibility study, aimed to provide initial clinical assessment of safety and effectiveness of the EndoZip in the treatment of obesity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2018-03-21
- Primary completion
- 2019-05-08
- Completion
- 2019-05-08
- First posted
- 2018-03-21
- Last updated
- 2021-02-23
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03472196. Inclusion in this directory is not an endorsement.