Design and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening

Abstract

ObjectiveCervical cancer screening usually requires use of a speculum to provide a clear view of the cervix. The speculum is one potential barrier to screening due to fear of pain, discomfort and embarrassment. The aim of this paper is to present and demonstrate the feasibility of a tampon-sized inserter and the POCkeT Colposcope, a miniature pen sized-colposcope, for comfortable, speculum-free and potentially self-colposcopy.Study designWe explored different designs using 3D computer-aided design (CAD) software and performed mechanical testing simulations on each. Designs were rapid prototyped and tested using a custom vaginal phantom across a range of vaginal pressures and uterine tilts to select an optimal design. Two final designs were tested with fifteen volunteers to assess cervix visualization, comfort and usability compared to the speculum and the optimal design, the curved-tip inserter, was selected for testing in volunteers.ResultsWe present a vaginal inserter as an alternative to the standard speculum for use with the POCkeT Colposcope. The device has a slim tubular body with a funnel-like curved tip measuring approximately 2.5 cm in diameter. The inserter has a channel through which a 2 megapixel (MP) mini camera with LED illumination fits to enable image capture. Mechanical finite element testing simulations with an applied pressure of 15 cm H2O indicated a high factor of safety (90.9) for the inserter. Testing of the device with a custom vaginal phantom, across a range of supine vaginal pressures and uterine tilts (retroverted, anteverted and sideverted), demonstrated image capture with a visual area comparable to the speculum for a normal/axial positioned uteri and significantly better than the speculum for anteverted and sideverted uteri (p<0.00001). Volunteer studies with self-insertion and physician-assisted cervix image capture showed adequate cervix visualization for 83% of patients. In addition, questionnaire responses from volunteers indicated a 92.3% overall preference for the inserter over the speculum and all indicated that the inserter was more comfortable than the speculum. The inserter provides a platform for self-cervical cancer screening and also enables acetic acid/Lugol’s iodine application and insertion of swabs for Pap smear sample collection.ConclusionThis study demonstrates the feasibility of an inserter and miniature-imaging device for comfortable cervical image capture of women with potential for synergistic HPV and Pap smear sample collection.

Portable Pocket colposcopy performs comparably to standard‐of‐care clinical colposcopy using acetic acid and Lugol's iodine as contrast mediators: an investigational study in Peru

“…The Pocket colposcope has gone through several iterations of speculum-based (21, 23) and speculum-free designs (24). This study was conducted using the latest generations of the speculum-based Pocket colposcope, which feature a waterproof design that enable the user to submerge the probe in chemical agents for high-level disinfection between patient uses (Figure 1A, B).…”

A Novel, Versatile Speculum-free Callascope for Clinical Examination and Self-Visualization of the Cervix

“…Our previous results also found that about 83% of users were able to view their cervix with physician assistance, consistent with our new results. 30 Future iterations of the device will include a channel for contrast agent administration and mucus removal.…”

“…We have previously published work on a low-cost, speculum-free, cervical visualization device, the Callascope. 30 We have also developed an android-based mobile application HIPPA (Health Insurance Portability and Accountability Act of 1996)compliant image capture and cloud storage. The Callascope consists of an inserter and a 2-megapixel (MP) off-the-shelf camera (Supereyes Y002) that fits in a channel in the inserter to enable image capture.…”

“…Mechanical finite element testing simulations, testing on custom vaginal phantoms, and evaluation on healthy volunteers demonstrated that this technology can serve as an effective alternative to the speculum for visualization of cervices with different orientations (due anteverted, retroverted, and sideverted uteri). 30 In addition, questionnaire responses from volunteers indicated that > 92% of them preferred the Calla compared to the traditional speculum. 30 This manuscript builds upon our previous work and reports on three distinct avenues of inquiry that directly serve to address the barriers described in the introduction: (1) a pilot clinical study to demonstrate the effectiveness of the Callascope for examination of the cervices of patients undergoing cervical cancer screening, (2) healthy volunteer studies where women performed a home-based self-exam after completion of a short training session in a clinical setting to demonstrate the feasibility of self-imaging in the absence of a health professional, and finally (3) pre-and post-surveys as well as audio reflections (in the self-imaging group only) to collect perceptions of the speculum, cervical cancer screening, and experiences with the Callascope.…”

“…30 In addition, questionnaire responses from volunteers indicated that > 92% of them preferred the Calla compared to the traditional speculum. 30 This manuscript builds upon our previous work and reports on three distinct avenues of inquiry that directly serve to address the barriers described in the introduction: (1) a pilot clinical study to demonstrate the effectiveness of the Callascope for examination of the cervices of patients undergoing cervical cancer screening, (2) healthy volunteer studies where women performed a home-based self-exam after completion of a short training session in a clinical setting to demonstrate the feasibility of self-imaging in the absence of a health professional, and finally (3) pre-and post-surveys as well as audio reflections (in the self-imaging group only) to collect perceptions of the speculum, cervical cancer screening, and experiences with the Callascope. The self-exam investigation differed from our previous healthy volunteer study in that women imaged their cervices independently, without a physician or health provider present and further used the device several times in their homes over a period of one week.…”