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Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™

NCT01261988 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-12-20

No results posted yet for this study

Summary

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.

Conditions

  • Ostomy

Interventions

DEVICE

VIPER

Comparison of ostomy systems

DEVICE

Esteem™ Cut to Fit One Piece Closed End Pouch

Comparison of ostomy systems

Sponsors & Collaborators

  • ConvaTec Inc.

    lead INDUSTRY

Principal Investigators

  • Qing Li, PhD · ConvaTec Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01261988 on ClinicalTrials.gov