Susan Bell, RN, MSN, CWOCN
Jobstown, New Jersey, 08041, United States
NCT Number: NCT01261988
The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Jobstown, New Jersey, 08041, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparison of ostomy systems
Comparison of ostomy systems
Time frame: 17 hours
All adverse events (AE's) related to the use of the device
Time frame: 17 hours
The number and percentage of subjects with study device fall-off during the study
Time frame: 17 hours
The total number of study device fall-offs during the course of the study
Time frame: 17 hours
Time frame: 1 hour
Initial tack of the adhesive (during first hour of wear)
Time frame: 17 hours
Ease of removal of the adhesive wafer from the skin
Time frame: 17 hours
Perceived security of the study pouch during wear
ConvaTec Inc.
Industry
A Single Center, Feasibility Study Using Healthy Volunteers to Assess the Safety and Adhesive Performance of the VIPER System When Compared to the Esteem™ Cut to Fit One Piece Closed End Pouch
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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