This study delivered statistically significant results, providing evidence of device efficacy. Among the many study achievements were high compliance—even among an older patient population—and lower costs.
Before the pandemic, Renovia, Inc. planned to conduct a 15-site study. But, in response to worldwide shutdowns and increased personal health awareness, they recognized that their target cohort—older female patients—may be too COVID-conscious to attend in-person visits. These new limitations prompted Renovia to investigate remote options.
There had never been a fully virtual study conducted in the urogynecology space. Renovia was navigating unknown territory in uncertain times. This clinical trial needed:
1. The ability to ensure safety and monitor for adverse events (AEs).
2. Patient training for both the treatment and control arms.
3. Coordination between the CRO and academic partners.
4. Reliable methods to recruit and retain a notoriously busy and hard-to-reach patient population.
ObvioHealth designed a fully virtual, randomized controlled clinical trial and managed the study process from start to finish.
ObvioHealth deployed a digital recruitment strategy using targeted advertising on social media. Creative assets were designed to appeal to women in specific age groups, decreasing cost per click.
Patients were trained on how to use the device using three different methods: a video, a pamphlet, and three phone calls. The phone conversations ensured patients were using the device correctly and allowed them the opportunity to ask questions.
ObvioHealth’s virtual site team—referred to as our COACH (Clinical Oversight and Coordination Hub) team—was available to provide support to patients at all times via live chat in the ObvioHealth app. The COACH team monitored adherence, answered questions about the trial, and offered tech support.
Renovia stakeholders included multiple academic institution partners as well as Mass General, who acted as the principal investigator (PI). ObvioHealth arranged a 15-minute daily meeting to ensure all stakeholders were updated on the progress of the study and to discuss any urgent issues.
Patients used the ObvioHealth app to record each bladder leak incident and trips to the bathroom. Patients input these outcomes in real time, increasing the accuracy of the data and reducing recall bias. The app also prompted patients to report changes in health status to help the clinician team to promptly identify AEs.
The study delivered statistically significant results for the device versus control group for two primary outcomes. The results of the study were published in ACOG’s Obstetrics and Gynecology.
350 patients recruited in 14 weeks
10x lower costs ($67 per patient)
93.5% ePRO compliance
22% of patients were above 65 years old (Oldest patient was 82)
"We knew we needed to make the study easy for our patients. We had the added stress of launching this trial at the height of the pandemic. ObvioHealth's virtual site delivered the support we needed for our patients, and their clinical science team provided expertise without the rigidity of a large CRO.
SVP of Clinical Operations at Renovia
ObvioHealth successfully conducted a clinical trial for RedHill Biopharma to test the safety and efficacy of an oral medication for the treatment of COVID-19 symptoms. We designed this decentralized study to be conducted where the majority of patients recover from illness—in their homes. When the trial was launched in 2021, its unique combination of home health visits, electronic patient-reported outcomes (ePRO), and remote monitoring devices was pioneering—COVID-19 studies were typically conducted inside hospitals.