Comparison Study of 3 Ostomy Products

Convatec

Status: Completed

Conditions: Ostomy

Treatments: Device: Ostomy accessory

Study type: Interventional

Funder types: Industry

Identifiers

NCT01691729

A739

Details and patient eligibility

About

To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products.

Full description

The primary objective of this study was to evaluate and compare the efficacy of three ostomy accessory products in terms of leakage and wear time. Secondary objectives were to evaluate and compare the safety of three ostomy accessory products, and to assess and compare the performance of the three products in terms of use and overall impression.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Has an ostomy
• Is at least 18 years of age
• Has a stoma for at least 3 months
• Other than thier ostomy is considered to have a healthy/stable health
• Is able to take care of their stoma

Exclusion criteria

• Known sensitivity to any of the ostomy devices or components
• Is undergoing chemotherapy or radiotherapy
• Has participated in a clinical study within the past 30 days
• Has a medical condition, in which in the opinion of the Investigator would not be a good candidate for the study and justifies exclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

26 participants in 6 patient groups

Ostomy 1

Other group

Description:

3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2

Treatment:

Device: Ostomy accessory

Ostomy 2

Other group

Description:

3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1

Treatment:

Device: Ostomy accessory

Ostomy 3

Other group

Description:

3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product

Treatment:

Device: Ostomy accessory

Ostomy 4

Other group

Description:

3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product

Treatment:

Device: Ostomy accessory

Ostomy 5

Other group

Description:

3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2

Treatment:

Device: Ostomy accessory

Ostomy 6

Other group

Description:

3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1

Treatment:

Device: Ostomy accessory