CPSD for Gastrostomy

Overseen By Paul A Lorentz, MS RN RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Tobacco, Illegal drugs, Gastric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new component of a feeding tube called the Constant Pressure Skin Disk (CPSD). Researchers aim to determine if this new disk can enhance wound healing and reduce complications after placing a feeding tube in the stomach or small intestine. Participants will receive standard care for tube placement along with the CPSD. This trial suits adults receiving a feeding tube for the first time who have not used tobacco or illegal drugs in the past year. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve patient care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Constant Pressure Skin Disk is safe for use in gastrostomy?

Research shows that the Constant Pressure Skin Disk (CPSD) helps heal and reduce issues for people with feeding tubes. Made from a type of liquid silicone rubber, studies have found this material is usually well-tolerated and similar to others safely used in medical devices.

While specific safety data for CPSD might not be available yet, its current testing suggests expected safety based on earlier lab and possibly human studies. Patients in previous studies have not reported major problems with this type of device.

Overall, the CPSD aims to safely support the area around the feeding tube and reduce issues like skin irritation or tube movement, leading to fewer complications and potentially a more comfortable experience for the user. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Constant Pressure Skin Disk (CPSD) is unique because it offers a novel approach to caring for patients with gastrostomy tubes. Unlike traditional care options that rely heavily on wound care and the prevention of pressure sores through frequent dressing changes, the CPSD provides consistent pressure distribution around the tube site. Researchers are excited about CPSD because it potentially reduces skin irritation and complications at the insertion site, which could lead to improved comfort and fewer hospital visits for patients. This continuous pressure distribution is a groundbreaking step beyond the usual standards of care, aiming to enhance the overall patient experience.

What evidence suggests that the Constant Pressure Skin Disk is effective for gastrostomy?

Research has shown that the Constant Pressure Skin Disk (CPSD), which participants in this trial will receive, might improve healing and reduce complications for people with feeding tubes. Early results suggest that the CPSD can safely and effectively aid the healing process when used with gastrostomy tubes. The CPSD applies steady pressure, which may help the skin heal better by preventing pressure sores and other issues around the tube site. While more information is needed, initial studies are promising for using CPSD to enhance care for feeding tube patients. ^{3 4 6 7 8}

Who Is on the Research Team?

Manpreet S Mundi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Age greater than or equal to 22 years

You recently had a tube inserted through your abdomen to help with feeding or medication.

Exclusion Criteria

History of an enteral tube

History of gastric surgery (bariatric surgery, Nissen fundoplication, etc.)

You have used tobacco or illegal drugs within the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

During the procedure, the gastroenterologist or interventional radiologist will replace the manufacturer's external, adjustable skin disk with the external, adjustable Constant Pressure Skin Disk (CPSD) by sliding the former off and the latter on to the feeding tube.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including the durability of the CPSD and any adverse events.

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Constant Pressure Skin Disk

Trial Overview 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.

How Is the Trial Designed?

Group I: Gastrostomy Tube Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study involving 18 patients, the insertion of disc-retained gastrostomy tubes showed a high displacement rate of 33%, with 22% of tubes completely displacing and 11% becoming occult in the peritoneum, indicating significant concerns about their stability.

The procedure also resulted in a 22% infection rate at the stoma site, leading to the conclusion that the Monarch gastrostomy tube is unsuitable for primary placement under current protocols, prompting a request for design reassessment from the distributor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disc-retained tubes for radiologically inserted gastrostomy (RIG): not up to the job? Kibriya, N., Wilbraham, L., Mullan, D., et al.[2013]

In a three-year study involving 13 children undergoing chronic peritoneal dialysis, a total of 781 dietetic contacts were made, highlighting the need for frequent dietary support, especially for younger children under 5 years old who had an average of 5.9 contacts per month.

Nutritional support via gastrostomy buttons was crucial, as evidenced by significant improvements in body mass index (BMI) from -0.91 to 0.17, indicating that tailored dietary interventions can enhance growth outcomes in children receiving CPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provision of dietetic care in children on chronic peritoneal dialysis. Coleman, JE., Norman, LJ., Watson, AR.[2019]

The use of a gastrostomy button device for long-term feeding in 10 children with chronic renal failure has proven effective, with 9 out of 10 achieving nutritional goals and improved growth parameters over a mean usage period of 12 months.

This method has significant advantages over traditional nasogastric tubes, including reduced stress for families and no need for surgery related to gastroesophageal reflux, making it a favorable option for managing feeding in young children with chronic renal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrostomy buttons for feeding children on continuous cycling peritoneal dialysis. Watson, AR., Coleman, JE., Taylor, EA.[2004]

The Janeway permanent gastrostomy technique offers a safe and effective feeding solution for brain-damaged children who cannot eat by mouth due to muscle incoordination.

This method, which uses a mucosal-lined tube flap from the stomach wall and can be easily constructed with a GIA stapler, avoids the drawbacks of traditional Stamm gastrostomy and provides a tubeless feeding option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Janeway gastrostomy in children with cerebral palsy. McGovern, B.[2019]

The skin-level nonrefluxing gastrostomy button (GB) was tested in 90 patients (50 children and 6 adults) over 20 months, showing promising results in managing long-term feeding needs with an average duration of 8.9 months for pediatric patients.

While the GB demonstrated effectiveness, there were some complications, including leakage and mechanical defects, leading to 31 changes in 20 children, indicating that while the device is beneficial, ongoing monitoring and potential replacements are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding gastrostomy button: experience and recommendations. Gauderer, MW., Olsen, MM., Stellato, TA., et al.[2019]

The Freka-button gastrostomy system was found to be easy to apply and safe for long-term use, with no major complications reported during a median follow-up of 248 days across 61 placements in 50 patients.

The system had a low failure rate of 0.26 per year, with most replacements needed due to balloon failure, indicating good long-term stability for this new gastrostomy tube.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Skin-level gastrostomy -- long-term results from a prospective trial in gastric and jejunal application]. Dormann, AJ., Deppe, H., Kahl, S., et al.[2009]

In a study of 481 patients who received either low-profile buttons (LPBs) or long gastrostomy tubes (LGTs), LPBs showed significantly lower rates of tube dislodgement (3% vs. 9%) and fewer emergency room visits for tube-related issues (31.6% vs. 43.9%).

The use of LPBs resulted in better overall tube-related outcomes, indicating they are a safer option for gastrostomy tube placement compared to LGTs, without increasing the risk of complications or readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Placement of a Low-Profile Gastrostomy Button Is Safe and Associated With Improved Outcomes in Children. Cortez, AR., Warren, PW., Goddard, GR., et al.[2020]

The modified Janeway gastrostomy technique, using an auto-stapling device, resulted in a low postoperative wound infection rate of only 3.8% among 26 patients.

After a mean follow-up of 257 days, 87% of patients maintained a continent gastrostomy, indicating the procedure's effectiveness for long-term care and patient acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The continent gastrostomy. Sriram, K., Peterson, J., Bawani, MH.[2004]

In a study of children with severe spastic cerebral palsy who underwent long-term gastrostomy, there were minimal differences in nutritional outcomes and complications between skin-level and tube gastrostomy devices.

Caregiver satisfaction did not significantly favor one device over the other, suggesting that the choice of gastrostomy device should be based on individual assessments of the child's and family's needs rather than manufacturer claims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative longitudinal study of gastrostomy devices in children. Thorne, SE., Radford, MJ.[2017]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/63536?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Feasibility of a Constant Pressure Skin Disk (CPSD) in En... The gastroenterologist or interventional radiologist will replace the manufacturer's external, adjustable skin disk with the external, ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20366125

Feasibility of a Constant Pressure Skin Disk (CPSD) ... The goal of this research study is to see if a new type of adjustable skin disk, called a Constant Pressure Skin Disk (CPSD), can safely and effectively support ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT03959878?keyword=%22Gastrostomy%22

Feasibility of a Constant Pressure Skin Disk (CPSD) ... Researchers are trying to see if a new type of adjustable skin disk, called a Constant Pressure Skin Disk (CPSD), can safely and effectively support adequate ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538736/

Gastrostomy versus Gastrojejunostomy and/or Jejunostomy ... Limited evidence from low quality nonrandomized studies suggests that gastrostomy tubes offer a modest benefit or no benefit when compared to jejunostomy tubes.

5. dirjournal.org dirjournal.org/articles/percutaneous-radiologic-gastrostomy-with-single-gastropexy-using-balloon-assisted-tract-dilatation-comparison-with-peel-away-sheath/dir.2023.232342

Percutaneous radiologic gastrostomy with single ... CONCLUSION. BATD using a single gastropexy is a safe and effective technique for PRG. RESULTS. All procedures were successfully performed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8098978/

Prevention and management of major complications in ... Gastrostomy tubes with an internal retention disc are at risk for progressive disc ... Transmural migration of gastrostomy tube retention discs.

7. portal.ct.gov portal.ct.gov/-/media/DDS/Health/NP091GastrostomyTubes.pdf

NP 09-1Gastrostomy Tubes This procedure is used in the placement of gastrostomy tubes, jejunostomy tubes and gastrojejunal tubes. Enteral feeding tube: a feeding device placed into the ...

8. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/endo/portfolio-group/EndoVive/ENDO-120211-AC-EndoVive_Family_Brochure_Refresh_18July2022_Final.pdf

EndoVive™ The new ENFit connector is designed to reduce risk of misconnections of the enteral feeding tube. All enteral access devices, including feeding tubes, ...