Poster CC1 - Usability of speculum-compatible injection devices for administering a low-cost ablative therapy to treat cervical dysplasia in low-and-middle income countries

Saturday, October 26, 2024

10:00 AM – 11:00 AM EST

Location: Exhibit Hall E, F & G

Presenting Author(s)

Vene Richardson-Powell (she/her/hers)

Research Assistant
Fischell Department of Bioengineering
Silver Spring, Maryland, United States

Co-Author(s)

Taya Lee (she/her/hers)

PhD Student
University of Maryland Bioengineering
College Park, Maryland, United States
BC

Brian Crouch, PhD

Assistant Research Professor in the Department of Biomedical Engineering
Duke University, United States
Nimmi Ramanujam, PhD

Professor of Biomedical Engineering at Duke University
Duke University, United States
Julie Hurvitz, MD

Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
University of Maryland School of Medicine, Maryland, United States

Primary Investigator(s)

Jenna Mueller, PhD (she/her/hers)

Assistant Professor
University of Maryland
College Park, Maryland, United States

Introduction: Cervical cancer is the fourth most commonly diagnosed cancer among women.1 Women living in low and middle-income countries (LMICs), who are diagnosed with cervical dysplasia (the precursor to cervical cancer), often do not return for follow-up care. This is primarily due to inaccessible treatments at the point of care.1 To address this unmet need, we developed a low-cost, accessible therapy that combines a biocompatible polymer, ethyl cellulose (EC) with ethanol to induce necrosis when injected into tissue.2 To administer EC-ethanol into the cervix, we previously developed two speculum-compatible injector prototypes, including a “single needle injector” that is more minimalistic in its design3 and a “multi needle injector” that can perform three injections simultaneously but is bulkier and more complex. We also created a third injector made from commercially available components, which we call the “extender injector”. Here we compared the usability of these three injectors through surveys and observations with clinical providers who used the injectors in a custom pelvic model.

Materials and

Methods: This study was approved by the University of Maryland School of Medicine IRB panel (IRB: HP-00108639). The single needle injector was previously described.3 Briefly, it contains a 3.5-inch 22G needle that has a footie used to adjust the insertion depth. The multi needle injector device is a novel device controlled by air pressure to push EC-ethanol through three 1-inch 22G needles. Lastly, the extender needle injector includes a 1-inch 22G needle, a needle stopper to control the depth of the injection, and a 6-inch-long stainless-steel needle extender (Figure 1A). To better understand user preference, obstetrics and gynecology (OB-GYN) providers (residents, fellows, and attendings) assessed each device using the Life/form Cervical Exam and Pap smear Test trainer (Nasco Healthcare, Saugerties, NY, USA) pelvic model. The plastic cervix in the model was replaced with a human-sized custom silicone cervix replicate made from Smooth On’s Ecoflex 00-40. This enabled providers to simulate injecting the cervix with EC-ethanol (Figure 1B). Each clinician was told to inject 6% EC-ethanol (w:v) into the model using all three devices and each injection was timed by our research team. After completion of the procedures, clinicians completed a survey rating device usability and preference using Likert scales.

Results, Conclusions, and Discussions: Results indicated that OB-GYN providers preferred the extender needle injector device when comparing the three cervical injector devices (Figure 1C). The survey Likert scales indicated that physicians preferred the design features of the extender device more than the single needle injector device and the multi needle injector device. Specifically, providers preferred the extender needle injector more than the single needle injector due to the single needle injector’s flimsiness causing depth uncertainty and resistance to inject the EC-ethanol. Providers noted the extender needle injector device had the least resistance when injecting the EC-ethanol solution. Providers did not prefer the multi needle injector due to its bulky size and lack of visibility of the cervix. Timed injection results indicated that the extender needle injector device had the lowest average injection time in seconds of 17.5 seconds compared to the single needle device with 41.2 seconds and the multi needle device with 83.9 seconds (Figure 1D). Taken together, OB-GYN providers prefer the extender needle injector, and it took significantly less time to perform EC-ethanol injection compared to the other injectors. Future work will include thorough testing in swine cervices to assess the repeatability of the injection cloud achieved with each injector.

Acknowledgements (Optional): This study was funded by the NIH (R44CA257303).