New Method for the Collection of the Output From the Ileostoma Using a Intestinal Tampon

Ileostomy - Stoma Clinical Trial

Official title:

First Study: InterPoc's Safety and Tolerability in Adults With Second Study: Safety and Functionality of InterPoc

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05891041
• Other study ID #: H-23000001
• Status: Completed
• Start date: April 26, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: December 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1 study: A pilot study of 8 adults with ileostomy was included in this trial of "first in human" with InterPoc™, an absorbent intestinal tampon safety and feasibility in humans with ileostomies.

Study 2: A study in total with 24 participants, evaluating both the safety but also the functionality of InterPoc in humans with ileostomies.

Description:

Approximately 1 million individuals with ileostomies face limitations in design and complications with traditional stoma bags dating back to the 1950s. Colostomy care alternatives are unavailable for ileostomy patients, prompting the development of InterPoc™, an absorbent intestinal tampon.

The first study aims to assess its safety and feasibility in humans, while the second study focuses of the overall safety and functionality of the tampon in all 24 participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 1, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of at least 18 Ileostoma at least created 6 months prior Ileostoma opening of at least 15 mm

Exclusion Criteria:

Inflamatory condition in the stoma or other intestine diagnosed within 2 months of the study Parastomal hernia daily output above 2 litters

Related Conditions & MeSH terms

• Ileostomy - Stoma

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København Ø	Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours	Safety of Interpoc during use	6 hours
Secondary	Pain during interpoc use	Using the NRS from 0-10	6 hours
Secondary	Early warning score during interpoc use (vital signs Pulse, blood pressure, oxygen saturation, respiratory rate, temperature),	A low score is better than a high score	6 hours
Secondary	Scale (0-10) score of Discomfort, acid reflux, nausea	A low score is better than a high score	6 hours
Secondary	InterPoc™ weight before and after insertion	For comparable	6 hours
Secondary	Leakage around the stoma pouch	Scale: 1-3)	6 hours
Secondary	Fecal output in stoma bag (ml) before and after the trail	scale 1-3	6 hours
Secondary	InterPoc™ Skin Irritation	(Scale: 1-3)	6 hour
Secondary	Insertion and removal resistance	scale 1-3)	6 hour
Secondary	Food consumption	descriptive	6 hour