NCT01753609

Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers

Safety and Performance Evaluation of TrimWeight Device - an Intragastric Auto-inflating & Degradable Balloon in a Swallow-able Capsule ("the Device"), for Enhancing Satiety and Satiation in Healthy Over Weight and Obese Volunteers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Tulip Medical Ltd. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon

Detailed description

The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon, packed in a swallow-able capsule, in healthy subjects with 30 \< BMI≤ 35.

Conditions

• Over Weight
• Obesity

Interventions

Type	Name	Description
DEVICE	Tulip capsule	swallowing Tulip capsule for up to 29 days

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-03-01
• Completion: 2013-07-01
• First posted: 2012-12-20
• Last updated: 2012-12-20

Locations

1 site across 1 country: Israel