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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05891041

Enrollment

Registered

2023-06-06

Start date

2023-04-26

Completion date

2023-10-01

Last updated

2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy - Stoma

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours	6 hours	Safety of Interpoc during use

Secondary

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

Countries

Denmark

Outcome results