Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

intragastric balloon, gastric balloon, endoscopic bariatric therapy, weight loss, total body weight loss, minimally invasive, GastricOn

Outcome Measures

Primary Outcomes (2)

Percentage of Total Body Weight Loss (%TBWL)
Percentage of total body weight lost from baseline, calculated as \[(baseline weight - Week 26 weight) / baseline weight\] × 100. Body weight will be measured at each study visit using calibrated scales.
Baseline to Week 26
Incidence of Device- and Procedure-Related Serious Adverse Events (SAEs)
Percentage of participants who experience at least one serious adverse event related to the GastricOn 6-Month Gastric Balloon or to the placement or removal procedure. The study's safety target is an SAE rate below 15%.
From balloon placement to Week 26

Study Arms (1)

the efficacy and safety of the GastricOn

EXPERIMENTAL

the efficacy and safety of the GastricOn 6-Month Gastric Balloon with respect to weight loss

Device: GastricOn intragastric balloon

Interventions

GastricOn intragastric balloonDevice

The GastricOn 6-Month Gastric Balloon is a saline-filled intragastric balloon placed endoscopically under mild sedation. After insertion, it is filled with 400-700 cc of sterile saline and released to float freely in the stomach, where it occupies space to promote early satiety and reduce food intake. Compared with earlier-generation balloons, it has an optimized shape and expandable volume intended to improve positioning and comfort, and a specially coated surface intended to reduce gastric ulceration and premature deflation. The balloon remains in place for 24 weeks and is then removed endoscopically under mild sedation. During treatment, participants take a prescribed proton pump inhibitor and follow a supervised diet and behavioral modification program.

Also known as: IGB

the efficacy and safety of the GastricOn

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Age ≥18 and ≤60 years.
BMI ≥30 kg/m² and ≤40 kg/m².

Sponsors & Collaborators

Rigicon, Inc.
Industrylead

Study Sites (1)

İstanbul Aydın Üniversitesi VM Medical Park Florya Hastanesi

Istanbul, Turkey (Türkiye)

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Enrollment

42 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 13, 2026

Study Start

December 18, 2025

Actual (reported)

Gastric On in Obesity Management: Evaluation of the Safety and Efficacy of the 6-Month Gastric Balloon (Prospective)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

the efficacy and safety of the GastricOn

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Gastric On in Obesity Management: Evaluation of the Safety and Efficacy of the 6-Month Gastric Balloon (Prospective)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

the efficacy and safety of the GastricOn

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations