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

NCT05477069 | Completed

• 1 other identifier: 38RC18.011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Innovative medical device; Microbiota; Biochemically controlled capsule; Intestinal fluid sampling

Outcome Measures

Primary Outcomes (1)

• Demonstrate the absence of adverse events (safety of the medical device) and that the device is analyzable (performance of the medical device).

  Safety is assessed with the absence of grade \>3 adverse events. Performance is assessed by the presence of at least one capsule found in the stool with a satisfactory visual condition of capsule and with a sufficient volume of its contents within 96 hours after ingestion. The primary objective of this study is met if safety and performance are achieved for at least 12 of 15 volunteers.

  From 96 hours to 15 days

Secondary Outcomes (8)

• Number and grade of adverse events collected during the capsule collection period

  From 96 hours to 15 days

• Number of capsules found to verify that the medical device passes through the human body

  From 96 hours to 15 days

• Verify that the medical device has captured intestinal fluid

  From 96 hours to 15 days

• Verify that the medical device has opened in the intestine

  From 96 hours to 15 days

• Absence of tears and detachment of the various elements of the capsule

  From 96 hours to 15 days

Study Arms (1)

First intervention group

EXPERIMENTAL

The volunteer ingests the medical device which passes through the body for a period of 12 to 24 hours. Capsules are collected and analysis on intestinal fluid and faeces are performed

Device: Innovative medical device for sampling small intestine content

Interventions

Innovative medical device for sampling small intestine content DEVICE

Ingestion of the medical device by the volunteer

First intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the study and the associated instructions
• Aged ≥18 years and ≤65 years
• Fasting with water and food for at least 10 hours
• BMI between ≥20 and ≤30 kg/m².
• Transit evaluated at 1 to 3 bowel movements/day
• Maintain regular physical activity and eating habits for the duration of the study
• Affiliated with a social security plan
• Have a freezer in their home and at work, if applicable
• Volunteer staying in the Isère department during the collection of the faeces (from 96 hours to 15 days max)
• Having signed the informed and collection consent

You may not qualify if:

• Subject :
• with medical treatment (except oral contraception and/or probiotics and related products)
• with lactose and fructose intolerance
• with of gastroparesis
• who receive more than 4500 euros of compensation due to his participation in other biomedical research in the 12 months preceding this study
• who cannot be contacted in case of emergency
• who has taken during the previous 7 days: at least once a treatment for irritable bowel syndrome (antispasmodics,..) or for constipation (laxative) or for diarrhea
• with a known food allergy
• who have to undergo colon surgery
• with intestinal obstruction history
• with hepatic, cardiac, congenital or renal comorbidity
• with long-standing diabetes
• with an inflammatory disease of the digestive tract, a history of digestive surgery
• who have been treated with radiotherapy or who have taken anti-inflammatory drugs for a long time
• with gastric fullness

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Clinical Investigation Centre for Innovative Technology Network: collaborator
• Pelican Health: collaborator

Study Sites (1)

University Hospital Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (2)

• Tronel A, Silvent AS, Buelow E, Giai J, Leroy C, Proust M, Martin D, Le Gouellec A, Soranzo T, Mathieu N. Pilot Study: Safety and Performance Validation of an Ingestible Medical Device for Collecting Small Intestinal Liquid in Healthy Volunteers. Methods Protoc. 2024 Feb 4;7(1):15. doi: 10.3390/mps7010015.

  PMID: 38392689 RESULT

• Tronel A, Roger-Margueritat M, Plazy C, Cunin V, Mohanty I, Dorrestein PC, Soranzo T, Le Gouellec A. Untargeted and semi-targeted metabolomics approach for profiling small intestinal and fecal metabolome using high-resolution mass spectrometry. Metabolomics. 2025 Jun 19;21(4):84. doi: 10.1007/s11306-025-02288-2.

  PMID: 40537703 DERIVED

Study Officials

• Nicolas Matthieu, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 28, 2022
• Study Start: October 24, 2022
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: August 13, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)