DySIS Medical, Inc., a medical device company, and Unified Women’s Clinical Research (UWCR), a subsidiary of Unified Physician Management in Boca Raton, Florida, have entered into a multi-center research partnership in DySIS Advanced Cervical Imaging System trial – a next-generation colposcope with computer-aided cervical imaging tools that is used to assess women after an abnormal Pap smear.
UWCR is a premier research organisation that provides excellent proficiency in gynecologic trial execution through our unique alliance of OB/GYN women’s health practices across the southeast. UWCR has conducted clinical trials on investigational medications, devices, gene therapy, and vaccines and our investigators have accumulated over 19 years of experience conducting more than 200 phase I-IV trials.
UWCR will become a significant part of DySIS Medical’s IMPROVE-COLPO study, the objective of which is to measure outcome improvements with the DySIS colposcope compared to standard colposcopy. The FDA-cleared imaging technology standardizes colposcopy and produces an intuitive color-coded map, similar to a weather map, to assist physicians in identifying, documenting and biopsying abnormal areas of the cervix.
“We are extremely excited to be a significant part of the IMPROVE study and to offer this promising new technology to our patients and providers,” said Dr. Lamar Parker, president of UWCR. “We believe our investigators can offer DySIS Medical significant value due to our extensive experience in medical device research and we look forward to mutually beneficial partnership.”
“We are thrilled to form a research partnership with a premier women’s health organisation with this level of clinical research experience,” added DySIS Medical’s US president, Kim Stebbings.
“Our agreement has allowed us to complete contracting for the trial’s 9000 subject objective in 40+ community and academic sites. We believe this will significantly accelerate our data collection toward our ultimate goal of demonstrating the value of this exciting technology – already named in UK Cervical Screening Guidelines.”