NCT05477069

Feasibility Study of an Innovative Medical Device for Sampling the Contents of the Small Intestine.

Feasibility Study of an Innovative Medical Device for Sampling the Contents of the Small Intestine. Functional Evaluation on the Transit of Healthy Volunteers. A First in Man, Prospective, Monocentric, Not Randomized Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

For the first time in the world, the objective of this study is to evaluate on healthy volunteers, an innovative medical device for the capture of intestinal liquid.This medical device is not yet CE marked.

Detailed description

This medical device consists of a standard pill made of 3 capsules for the collection of intestinal microbiota. The pill is ingested by the volunteer and multi-omics analysis will be performed on intestinal fluid samples from the capsules and also on faeces. First in man, involving a medical device, prospective, monocentric, not randomized, not controlled and open-label study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	Innovative medical device for sampling small intestine content	Ingestion of the medical device by the volunteer

Timeline

• Start date: 2022-10-24
• Primary completion: 2023-11-06
• Completion: 2023-11-06
• First posted: 2022-07-28
• Last updated: 2025-08-13

Locations

1 site across 1 country: France