ClinicalTrials.gg
CompletedNCT01261988Updated Dec 20, 2010

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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.

02

Conditions studied

  • Ostomy
03

In context

Lead sponsor

ConvaTec Inc. is the lead sponsor of 46 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female between 18 and 70 years of age (inclusive) at the time of randomization
  • Willing and able to provide written informed consent and HIPAA Waiver
  • An appropriate candidate for participation with unbroken non-irritated abdominal skin
  • Willing to adhere to the study procedures and to attend the scheduled study visits according to the requirements of the study protocol
  • Willing to adhere to the scheduled study visits
  • Good manual dexterity and be able to take care of their abdominal area independently
  • Be willing and able to record the required study data in a specified format

Exclusion criteria

Exclusion Criteria:

  • A history of a known sensitivity or allergy to System 3+ adhesive (modified Stomahesive® technology), Stomahesive®, Durahesive®, Polyethylene Film, or polyester fiber,or to any adhesive components in general as listed in the Investigators Brochure.
  • Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
  • Subjects with any chronic allergies requiring the use of prescription medication
  • History of skin disease affecting abdominal area
  • Currently uses topical ointments in the area of the abdomen or is unwilling/unable to terminate over the counter use of topical ointments in the area of the abdomen
  • Active case of eczema, dermatitis, psoriasis
  • Pregnant or lactating females.
  • Subject currently enrolled in another investigational study
  • Possesses extensive knowledge about either product (ie employees that re members or extended members of the Core Team work in ostomy research and development, or ostomy division sales and marketing )
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Interventions

  • DeviceVIPER

    Comparison of ostomy systems

  • DeviceEsteem™ Cut to Fit One Piece Closed End Pouch

    Comparison of ostomy systems

06

What researchers measure

Primary outcomes

  1. Safety: Related Events

    All adverse events (AE's) related to the use of the device

    Time frame: 17 hours

  2. Efficacy: Device Fall-Offs

    The number and percentage of subjects with study device fall-off during the study

    Time frame: 17 hours

  3. Efficacy: Device Fall-Offs

    The total number of study device fall-offs during the course of the study

    Time frame: 17 hours

  4. Safety: Skin Reactions

    Time frame: 17 hours

Secondary outcomes

  1. Adhesive

    Initial tack of the adhesive (during first hour of wear)

    Time frame: 1 hour

  2. Ease of Removal

    Ease of removal of the adhesive wafer from the skin

    Time frame: 17 hours

  3. Security

    Perceived security of the study pouch during wear

    Time frame: 17 hours

07

Study locations

1 site
  • Susan Bell, RN, MSN, CWOCN
    Jobstown, New Jersey 08041, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01261988
Lead sponsor
ConvaTec Inc.
First posted
Dec 17, 2010
Start date
Dec 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Dec 20, 2010

Study contacts

Qing Li, PhD
study director · ConvaTec Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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