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A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin

NCT04544566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-05-06

Study results available
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Summary

An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.

Conditions

  • Stoma Site Leakage

Interventions

DEVICE

Test product A

one new adhesive material which is applied to the baseplate and the subjects peristomal skin

DEVICE

Test product B

one new adhesive material which is applied to the baseplate and the subjects peristomal skin

DEVICE

Comparator

Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Tonny Karlsmark, MD · Bispebjerg hospital, Dermato-Venerologisk afdeling.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2020-08-21
Completion
2020-08-21

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04544566 on ClinicalTrials.gov