ProVerum this week announced it completed enrollment in its ProVIDE pivotal clinical trial to evaluate the safety and effectiveness of the ProVee system.
The ProVIDE clinical trial is a prospective, multicenter, double-blind controlled study that evaluates the safety, performance, and effectiveness of the ProVee system in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). Dublin-based ProVerum enrolled 221 subjects across 15 investigational sites in the U.S. and two international sites.
ProVee is a ‘stent-like’ expander that gently opens an obstructed urethra and alleviates the symptoms caused by BPH. It avoids the need for surgery and requires no heating, cutting, piercing or removal of the prostate. ProVerum designed the device to preserve sexual function and provide a rapid return to normal activity. It is intended to be performed in the doctor’s office or operating room without general anesthesia.
The device fits within the prostate between the bladder neck and the verumontanum and is non-disruptive to the external sphincter verumontanum and bladder neck. According to ProVerum, ProVee is preloaded in a sterile, low-profile, custom delivery system for a more patient-friendly procedure. Although it is designed and evaluated as a permanent implant, the nitinol material in the device allows for retrieval if needed.
“The ProVee System has the potential to be a first-line interventional therapy (FIT) for BPH that can be safely and reliably performed in the office setting,” Dr. Steve Kaplan, Professor of Urology at the Icahn School of Medicine at Mount Sinai in New York and global lead investigator for the ProVIDE study, said in a news release. “This large international, multi-center clinical study, which is now fully enrolled, thoroughly evaluates the safety, efficacy and long-term durability of the ProVee device and I look forward to presenting the data.”
ProVerum enrolls first patient in ProVIDE II study
The company also announced it began its ProVIDE II Bridging Study that will evaluate the performance of its new low profile flexible, steerable delivery system for deploying the ProVee expander.
ProVee’s expander is a second-generation delivery system with the same diameter as a diagnostic cystoscope. It is suited to an office or outpatient setting. It is flexible and steerable and allows patients to lay flat during the procedure rather than having to have their legs in stirrups. ProVerum said there is no change to the ProVee expander.
The first procedure was successfully performed by Dr. Brian Mazzarella, principal investigator at Urology Austin, Texas.
“The new delivery system is straightforward to use and works similarly to a flexible cystoscope that all urologists use routinely in the office setting,” Mazzarella said. “I see many dissatisfied patients whose BPH symptoms are not resolved by medication yet they are unwilling to undergo more invasive surgical procedures. The atraumatic nature of ProVee may make it an option that patients would actually choose to have and thus improve their lives and avoid further bladder damage.”
