Clinical Trials Logo
  1. Home
  2. Gastrostomy
  3. NCT03959878
  4. Details
NCT03959878 Clinical Trial

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

Gastrostomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03959878
Other study ID # 16-001922
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2019
Est. completion date December 2025

Study information
Verified date April 2024
Source Mayo Clinic
Contact Paul A Lorentz, MS RN RD
Phone 507-255-7121
Email lorentz.paul@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Researchers are gathering information on one specific part of a feeding tube, known as the adjustable skin disk. 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 healing, and reduced complication rates.

Description:

During the procedure of placing a gastrointestinal gastrostomy tube (GIG tube) or GI jejunostomy tube (GIJ tube), 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: - Age greater than or equal to 22 years - Undergoing PEG tube or PEJ tube placement Exclusion Criteria: - History of tobacco or illegal drug use in the past year - History of an enteral tube - History of gastric surgery (bariatric surgery, Nissen fundoplication, etc.)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Constant Pressure Skin Disk
The external disk is made of Dow Corning® Silastic Q7-4850 liquid silicone rubber. Placement of the disk will be done by the gastroenterologist or interventional radiologist during the gastrointestinal gastrostomy tube (GIG) or gastrointestinal jejunostomy tube (GIJ) placement procedure. The gastroenterologist or interventional radiologist will replace the manufacturer's external, adjustable skin disk with the external, adjustable Constant Pressure Skin Disk, by sliding the former off and the latter on to the feeding tube.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Constant Pressure Skin Disk (CPSD) durability Number of devices that remain intact 180 days
Secondary Adverse Events Number of adverse events reported 180 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04566367 - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer N/A
Recruiting NCT04110613 - RCT: Early Feeding After PEG Placement N/A
Completed NCT03319576 - Early Feeding Following Percutaneous Gastrostomy Tube Placement N/A
Completed NCT03575754 - A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique N/A
Enrolling by invitation NCT06129877 - CHAMP App Feeding Difficulties Repository
Completed NCT04183296 - The Effect of Total Intravenous Anesthesia and Volatile Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Laparoscopic or Robotic Assisted Gastrectomy N/A
Recruiting NCT02909205 - a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised N/A
Recruiting NCT04636099 - Gastrointestinal Surgery Study Group 2001 N/A
Not yet recruiting NCT05955534 - Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy N/A
Completed NCT02869321 - Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy Phase 4
Recruiting NCT05205343 - Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
Recruiting NCT03874871 - Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients
Completed NCT03252509 - Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors N/A
Completed NCT04804631 - Tube Feeding in Children Having a Bone Marrow Transplant
Terminated NCT01825564 - Comparison of RightSpot pH Indicator & RightLevel pH Detector With X-Ray Verification for FT or G-Tube Placement N/A
Completed NCT04919577 - Predictive Factors for Roux Stasis Syndrome
Completed NCT04151030 - Endoscopic Direct-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure N/A
Completed NCT05994079 - Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy N/A
Recruiting NCT04808206 - A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
Recruiting NCT05966311 - Pediatric Percutaneous Ultrasound Gastrostomy Technique N/A