MIPS Project Detail:
Company
Company Description:
CoapTech seeks to bring a series of breakthrough medical devices to worldwide markets, leveraging a patent-pending, disruptive technology called Coaptive Ultrasound. The company’s CoapTech Carrier™ is a novel platform technology combining magnetic attraction for device placement guidance and low-cost, point-of-care ultrasound for visual feedback in diagnostic, interventional and therapeutic procedures.
CoapTech is commercializing a kit that will enable clinicians to perform a novel procedural method called Percutaneous Ultrasound Gastrostomy (PUG) for the placement of semi-permanent feeding tubes in the stomach. PUG improves on Percutaneous Endoscopic Gastrostomy (PEG), the current standard of care for feeding tube placement. The company believes that PUG is a safer, simpler, and less expensive method for placing feeding tubes.
MIPS Project
Evaluating a Novel Gastrostomy Procedural Method
Project #
5912.21
|
MIPS Round
61
|
Starting Date:
Feb 2018
MIPS Project Challenge:
This MIPS research is designed as a two-phase project aimed at deploying a small clinical study leading to FDA clearance of this novel medical device. The first phase of the MIPS project will focus on study design and preparation. The second phase will focus on study implementation and evaluation.
Project’s Scope:
The specific aims of the project are: 1.) write a clinical protocol for a first-in-humans pilot study at the University of Maryland Medical Center; 2.) achieve Institutional Review Board (IRB) approval for the clinical study; and 3.) train study clinicians in the novel procedural method.
Results:
Principal Investigator:
Richard
Wilkerson
Director of Clinical Research
Project Manager:
Howard
Carolan
Co-Founder & CEO
Technologies:
Medical Instrumentation / Equipment
