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LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa

NCT05824351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-09-26

Study results available
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Summary

The purpose of this study is to examine the safety of the LowCostomy appliance's peristomal adhesive interface composed of a mix of beeswax and pine resin.

Conditions

  • Abdominal Site
  • Colostomy Site

Interventions

DEVICE

Tanzanian beeswax-pine resin

Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.

DEVICE

Domestic beeswax-pine resin

Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.

DEVICE

Hollister's AdaptTM Barrier Rings

Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.

Sponsors & Collaborators

Principal Investigators

  • Amy Barto, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-10
Primary Completion
2023-06-23
Completion
2023-06-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT05824351 on ClinicalTrials.gov