New Method for the Collection of the Output From the Ileo... | NCT05891041

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

NCT05891041

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Dec 29, 2023Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Ileostomy - Stoma

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2023Actual

Primary Completion Date

Sep 25, 2023Actual

Completion Date

Oct 1, 2023Actual

First Submitted Date

May 1, 2023

First Submission Date that Met QC Criteria

Jun 2, 2023

First Posted Date

Jun 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2023

Last Update Posted Date

Dec 29, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Patrick Achiam, DMSCI, associate professor, Rigshospitalet, DenmarkPrincipal Investigator

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pain during interpoc use	Using the NRS from 0-10	6 hours
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy patients with an ileostoma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael P Achiam	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		København Ø	Capital Region	2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided