A Clinical Pilot Study of Newly Developed Ostomy Tapes & How They Adhere

Clinical Trial Description

The test products are 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. ;

Study Design

Related Conditions & MeSH terms

Stoma Site Leakage

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04763863` - The Nordic Consensus Study
Terminated	`NCT04802538` - Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management	N/A
Completed	`NCT05652010` - Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma	N/A

See also

Status

Clinical Trial

Phase

Recruiting

NCT04763863 - The Nordic Consensus Study

Terminated

NCT04802538 - Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management

N/A

Completed

NCT05652010 - Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04544566
Study type	Interventional
Source	Coloplast A/S
Contact
Status	Completed
Phase	N/A
Start date	July 7, 2020
Completion date	August 21, 2020

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms