Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03959878|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastrostomy||Device: Constant Pressure Skin Disk||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 1, 2021|
Experimental: Gastrostomy Tube
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.
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.
- Constant Pressure Skin Disk (CPSD) durability [ Time Frame: 180 days ]Number of devices that remain intact
- Adverse Events [ Time Frame: 180 days ]Number of adverse events reported
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959878
|Contact: Paul A Lorentz, MS RN RDfirstname.lastname@example.org|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Paul A Lorentz, MS, RN, RD 507-255-7121 email@example.com|
|Principal Investigator: Manpreet Mundi, MD|
|Sub-Investigator: Paul Lorentz, MS, RN, RD|
|Principal Investigator:||Manpreet S Mundi, MD||Mayo Clinic|