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Device

CPSD for Gastrostomy

N/A

Recruiting

Led By Manpreet S Mundi, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

Study Summary

This trial is testing a new type of feeding tube disk to see if it is more effective than the current one in healing and reducing complications.

Who is the study for?

This trial is for adults aged 22 or older who are about to receive a PEG tube or PEJ tube for feeding. It's not open to those who've had an enteral tube before, any gastric surgery like bariatric surgery, or used tobacco or illegal drugs in the past year.Check my eligibility

What is being tested?

The study is examining a new type of adjustable skin disk called Constant Pressure Skin Disk (CPSD) that's part of a feeding tube setup. The goal is to see if CPSD can help with better healing and fewer complications compared to current options.See study design

What are the potential side effects?

Potential side effects aren't specified but may include irritation at the site where the feeding tube enters the skin, infection risk, discomfort from pressure changes, and possible interference with wound healing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Constant Pressure Skin Disk (CPSD) durability

Secondary outcome measures

Adverse Events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gastrostomy TubeExperimental Treatment1 Intervention

Non-hospitalized outpatients undergoing placement of a gastrointestinal gastrostomy tube (GIG tube) or GI jejunostomy tube (GIJ tube) will receive the usual Standards of Care related to the placement of a GIG or GIJ tube and the Constant Pressure Skin Disk.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,210 Previous Clinical Trials

3,767,137 Total Patients Enrolled

Manpreet S Mundi, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

72 Total Patients Enrolled

Media Library

Constant Pressure Skin Disk (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03959878 — N/A

Gastrostomy Research Study Groups: Gastrostomy Tube

Gastrostomy Clinical Trial 2023: Constant Pressure Skin Disk Highlights & Side Effects. Trial Name: NCT03959878 — N/A

Constant Pressure Skin Disk (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03959878 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this research still available to those interested?

"According to the data hosted on clinicaltrials.gov, this medical trial is currently recruiting for participants. It was initially posted September 30th 2019 and recently updated March 7th 2022."

Answered by AI

What is the participant count for this research effort?

"Affirmative, the information on clinicaltrials.gov confirms that this study is recruiting at present. Initially published on September 30th 2019, it was most recently revised on March 7th 2022 and requires 20 participants to be recruited from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.

Manpreet S. Mundi 2019. "Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03959878.