Stoma Ileostomy Clinical Trial
Official title:
Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy
Verified date | November 2015 |
Source | Coloplast A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Health and Medicines Authority |
Study type | Interventional |
The aim of the investigation was to investigate the performance and safety of a new ostomy product
Status | Completed |
Enrollment | 38 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Are at least 18 years of age and have full legal capacity. - Have had an ileostomy/colostomy for more than 3 months - Have used a 1-piece flat ostomy product for the last 1 month - Has given written Informed Consent and signed the letter of authority - Have an ileostomy or colostomy with a diameter of 33 mm or less - Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks - Are evaluated to be suitable for a soft convex product - If having a colostomy: changes their product on average 2 times pr. 24h or more - Currently uses a bag of size medi/midi or maxi Exclusion Criteria: - Have a loop ostomy (also called double-barrel or ostomy with two outlets). - Are pregnant or breastfeeding - Currently receiving or have within the past 2 month received radio- and/or chemotherapy - Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area - Currently suffering from peristomal skin problems (i.e. bleeding or broken skin). - Known hypersensitivity toward any of the test products - Participating in other interventional clinical investigations or have previously participated in this investigation - Use irrigation during the investigation (flush the intestine with water) - Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate - If subject has a colostomy: empties the bag |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Denmark | TFS | Søborg |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of Leakage | The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage. | 14 +/- 3 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06269276 -
Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study
|
||
Not yet recruiting |
NCT05076669 -
Quality of Life Impact After Enhanced Follow-up of Ostomy Patients
|
N/A | |
Terminated |
NCT03016195 -
Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies
|
N/A | |
Recruiting |
NCT04763863 -
The Nordic Consensus Study
|
||
Completed |
NCT05970458 -
Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden
|
||
Completed |
NCT05601024 -
The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma
|
N/A | |
Completed |
NCT05135754 -
Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation
|
N/A | |
Completed |
NCT01994902 -
Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
|
N/A | |
Recruiting |
NCT03424447 -
Stimulation of the Efferent Loop Before Loop Ileostomy Closure
|
Phase 2 | |
Recruiting |
NCT04984161 -
The Effect of Stoma Care Education on the Knowledge and Skill Levels of Pediatric Surgery Nurses
|
N/A | |
Completed |
NCT05531331 -
The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma
|
N/A | |
Active, not recruiting |
NCT06458699 -
Management Of Stoma In Patients Younger Than 3 Months Old
|
||
Recruiting |
NCT04374890 -
Evaluation of a New Supporting Ostomy Product
|
N/A | |
Not yet recruiting |
NCT06391398 -
The Impact of Education Using a Stoma Care Training Belt
|
N/A | |
Recruiting |
NCT04709445 -
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses
|
N/A | |
Completed |
NCT04744792 -
QoL of Colorectal Cancer Patients and Spouses
|
||
Completed |
NCT03971513 -
Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study
|
N/A | |
Completed |
NCT03200444 -
Evaluation of the Peel Force of New Adhesives From the Skin
|
N/A | |
Completed |
NCT03619226 -
Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
|
N/A | |
Completed |
NCT06237686 -
Clinical Investigation Exploring Two Ostomy Product Prototypes
|
N/A |