NCT05891041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

May 1, 2023

Last Update Submit

December 21, 2023

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Pain during interpoc use

    6 hours

  • Early warning score during interpoc use (vital signs Pulse, blood pressure, oxygen saturation, respiratory rate, temperature),

    6 hours

  • Scale (0-10) score of Discomfort, acid reflux, nausea

    6 hours

  • InterPoc™ weight before and after insertion

    6 hours

  • Leakage around the stoma pouch

    6 hours

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy patients with an ileostoma

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

København Ø, Capital Region, 2100, Denmark

Location

Study Officials

  • Michael P Achiam

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DMSCI, associate professor

Study Record Dates

First Submitted

May 1, 2023

First Posted

June 6, 2023

Study Start

April 26, 2023

Primary Completion

September 25, 2023

Study Completion

October 1, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)