Single center, prospective, single-arm feasibility study to evaluate the safety of the PlenSat Digestible Balloons in the treatment of Obesity

Completed

• Conditions: Obesity; severe overweight; 10003018

• Registration Number: NL-OMON46714
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

18-80 years of age
Able and willing to sign an informed consent document
BMI of 30-39.9 kg/m^2
Sufficient and stable medical health
Must have a primary care physician

Exclusion Criteria

Signs/symptoms of gastroduodenal ulcer disease (in history or present)
Poorly controlled diabetes or diabetes >10yr
Signs/symptoms of oesophageal or gastric disease (in history or present)
Signs/symptoms of dysmotility of gastrointestinal tract
Use of opioid drugs (past six weeks or present)
Female subject is pregnant or suspected to be pregnant, or lactating
Previous bariatric, gastric or oesophageal surgery
Swallowing disorders
Illicit drug use or alcohol abuse
Participation in other clinical study within past 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Duration of survival of the balloon inside the stomach is the main outcome of<br /><br>this study. Furthermore, a safety analysis will assess the occurrence of<br /><br>adverse events (AEs), serious adverse device effects (SADEs) and serious<br /><br>adverse events (SAE), monitored from the moment of ingestion of the capsule up<br /><br>to two weeks after observed digestion. Self-reported scores on symptoms of<br /><br>reflux and dyspepsia will complement the safety analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>