Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 6:05 PM
Study NCT ID:
NCT07195708
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Clinical Study to Evaluate the Safety and Efficacy of the Orbera365 Intragastric Balloon System in Obese Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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:
To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.
Detailed Description:
The study is a prospective, multicenter, randomized controlled, non-blinded trial.
The treatment group was the group with the placement of Orbera 365 plus lifestyle management, while the control group was the lifestyle management group. The central randomization system was adopted to randomly assign the research subjects into the experimental group and the control group. The subjects were enrolled at a 1:1 ratio, with 72 cases in each group, making a total of 144 cases.
The subjects in the treatment group will be followed up until 6 months after the balloon removal or 12 months after the endoscopy procedure, whichever comes later. The control group is planned to receive a 12-month lifestyle intervention, and the maximum follow-up period is up to 18 months.
The treatment group was the group with the placement of Orbera 365 plus lifestyle management, while the control group was the lifestyle management group. The central randomization system was adopted to randomly assign the research subjects into the experimental group and the control group. The subjects were enrolled at a 1:1 ratio, with 72 cases in each group, making a total of 144 cases.
The subjects in the treatment group will be followed up until 6 months after the balloon removal or 12 months after the endoscopy procedure, whichever comes later. The control group is planned to receive a 12-month lifestyle intervention, and the maximum follow-up period is up to 18 months.
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?:
True
Is an FDA AA801 Violation?: