Feasibility Study of an Innovative Medical Device for Sam... | NCT05477069

NCT05477069

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Clinical Investigation Centre for Innovative Technology Network	NETWORK
Pelican Health	UNKNOWN

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Innovative medical device for sampling small intestine content	Device	Ingestion of the medical device by the volunteer	First intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number and grade of adverse events collected during the capsule collection period	In order to verify the safe use of the medical device the number and grade of adverve events are collected from 96 hours to 1 month.	From 96 hours to 15 days
Number of capsules found to verify that the medical device passes through the human body

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Subject :

with medical treatment (except oral contraception and/or probiotics and related products)
with lactose and fructose intolerance
with of gastroparesis
who had a colonoscopy preparation up to 1 month prior to inclusion
in the exclusion period of another clinical investigation,
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 15 days prior to inclusion and/or is scheduled to take the following treatments during the study: antidepressants, anxiolytics, antiparkinsonian agents, neuroleptics, antibiotics and prebiotics
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
with known or suspected obstruction of the gastrointestinal tract (including known inflammatory bowel or intestinal diverticula)
with presence of swallowing disorders or Zencker's diverticulum
with nausea, deviated nasal septum
with contraindications to esophageal tube placement (chronic esophageal pathology)
drug or alcohol abuse (3 units for men and 2 units for women according to WHO criteria)
with a known allergy to silicone or to iodine
refusing medical imaging or surgery (in case of non-recovery of the capsule)
protected person concerned by the articles L1121-5 to L1121-8 of the Public Health Code
absence of highly effective contraception for women with childbearing capacity until the end of the cycle following the end of participation in the trial

PubMed Identifier	Type	Citation	Retractions
38392689	Result	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.
40537703	Derived