Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00707720
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2008-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-Center Feasibility Study of Trans-oral Endoscopic Restrictive Implant System (TERIS) for Treatment of Obesity
Sponsor:
BaroSense Inc.
Organization:
Study Overview
Official Title:
Multi-center Feasibility Study to Evaluate the Safety of the Trans-oral Endoscopic Restrictive Implant System (TERIS) for the Treatment of Obesity
Status:
COMPLETED
Status Verified Date:
2013-04
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:
The Barosense Trans-oral Endoscopic Restrictive Implant System (TERIS) is an investigational system being evaluated for safety The system uses endoscopic guidance to trans-orally implant a restrictive reservoir for food entering the stomach in obese and morbidly obese subjects to induce early and prolonged satiety. The Intended Use of the system is for the treatment of obesity.
Detailed Description:
Obesity is now considered to be epidemic through most of the industrialized world. The consequences of obesity on long-term health of individuals is now well documented. While lifestyle changes in diet and activity level are the key instruments to arresting or reversing this condition, conventional medically supervised programs have proven only marginally effective. Bariatric surgery has shown to be a reliable long-term treatment for reducing excess body weight. Though surgical techniques have evolved and complication rates have been reduced, surgery on these patients still carries significant mortality and morbidity.
Techniques and instruments are now being developed to allow for Endoscopic approaches to these procedures that will aim to reduce the complications associated with open or laparoscopic technique for these procedures.
The primary objective of this study is to evaluate the safety of the Trans-oral Endoscopic Restrictive Implant System (TERIS) procedure for the treatment of obesity over a six month follow-up period.
A secondary objective is to perform a preliminary evaluation of the efficacy of the TERIS procedure in order to guide the design of future studies, including a pivotal trial.
This is a prospective feasibility study at up to 3 investigational sites of up to 40 subjects who are obese and have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone, or in combination. Up to 60 subjects may be enrolled, and undergo baseline evaluation in order to obtain a final total of up to 40 subjects appropriate for trans-oral implant. Barosense intends to use data from this study in support of subsequent investigational studies, including a pivotal trial
Techniques and instruments are now being developed to allow for Endoscopic approaches to these procedures that will aim to reduce the complications associated with open or laparoscopic technique for these procedures.
The primary objective of this study is to evaluate the safety of the Trans-oral Endoscopic Restrictive Implant System (TERIS) procedure for the treatment of obesity over a six month follow-up period.
A secondary objective is to perform a preliminary evaluation of the efficacy of the TERIS procedure in order to guide the design of future studies, including a pivotal trial.
This is a prospective feasibility study at up to 3 investigational sites of up to 40 subjects who are obese and have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone, or in combination. Up to 60 subjects may be enrolled, and undergo baseline evaluation in order to obtain a final total of up to 40 subjects appropriate for trans-oral implant. Barosense intends to use data from this study in support of subsequent investigational studies, including a pivotal trial
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: