Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01957397
Other study ID # CP230
Secondary ID
Status Completed
Phase N/A
First received October 1, 2013
Last updated February 26, 2014
Start date October 2012
Est. completion date December 2012

Study information

Verified date February 2014
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines Authority
Study type Interventional

Clinical Trial Summary

To investigate the performance and safety of the three 2-piece convex ostomy appliances


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Subjects interested in participating in the clinical investigation must comply with the following criteria:

1. Are at least 18 years of age and have full legal capacity

2. Have had an ileostomy for at least 3 months.

3. Have used a convex ostomy appliance for the last month

4. Have given written informed consent

5. Have an ileostomy with a diameter of 33mm or less

6. Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion Criteria:

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)

2. Are pregnant* or breastfeeding.

3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.

4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.

5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).

6. Known hypersensitivity toward any of the test products

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
Coloplast Test 1
Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2
Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3
Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance

Locations

Country Name City State
Denmark Coloplast A/S Humlebæk

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of Leakage The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage uner baseplate) 14 days No
See also
  Status Clinical Trial Phase
Terminated NCT03746353 - Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer N/A
Completed NCT03331783 - Assessment of the Effect of Output on New Adhesives N/A
Completed NCT02920294 - Modulation of Microbial Composition in Ileostomy Patients N/A
Completed NCT02886455 - Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives N/A
Completed NCT02517541 - A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products N/A
Completed NCT01957553 - Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece N/A
Completed NCT01939600 - Digestibility of Selected Resistant Starches in Humans N/A
Terminated NCT01994863 - Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy Phase 2
Completed NCT01994876 - Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy N/A
Completed NCT03289013 - Assessement of the Peal Force Needed to Peel New Adhesives From the Skin N/A
Terminated NCT03416023 - Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy N/A
Completed NCT02997267 - Early Closure of Protective Ileostomy in Rectal Cancer Patients N/A
Recruiting NCT01880918 - A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing N/A
Recruiting NCT04577456 - Chyme Reinfusion for Type 2 Intestinal Failure N/A
Terminated NCT03587519 - Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery N/A
Recruiting NCT03872271 - Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial N/A
Completed NCT04606004 - Perianal Maceration in Pediatric Ostomy Closure Patients N/A
Completed NCT02886403 - Evaluation of the Influence of Output on a Newly Develop Adhesive N/A
Recruiting NCT03424447 - Stimulation of the Efferent Loop Before Loop Ileostomy Closure Phase 2
Completed NCT03770078 - Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma N/A