A Phase 1 interventional study of VIPER and Esteem™ Cut to Fit One Piece Closed End Pouch in Ostomy, sponsored by ConvaTec Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-20.
Sponsored by ConvaTec Inc. · Phase 1, Interventional, and Treatment
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.
ConvaTec Inc. is the lead sponsor of 46 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Comparison of ostomy systems
Comparison of ostomy systems
Safety: Related Events
All adverse events (AE's) related to the use of the device
Time frame: 17 hours
Efficacy: Device Fall-Offs
The number and percentage of subjects with study device fall-off during the study
Time frame: 17 hours
Efficacy: Device Fall-Offs
The total number of study device fall-offs during the course of the study
Time frame: 17 hours
Safety: Skin Reactions
Time frame: 17 hours
Adhesive
Initial tack of the adhesive (during first hour of wear)
Time frame: 1 hour
Ease of Removal
Ease of removal of the adhesive wafer from the skin
Time frame: 17 hours
Security
Perceived security of the study pouch during wear
Time frame: 17 hours
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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