A Non–Gas-Based Cryotherapy System for the Treatment of Cervical Intraepithelial Neoplasia: A Mixed-Methods Approach for Initial Development and Testing

Cremer, Miriam; Paul, Proma; Bergman, Katie; Haas, Michael; Maza, Mauricio; Zevallos, Albert; Ossandon, Miguel; Garai, Jillian; Winkler, Jennifer L.

doi:10.9745/ghsp-d-16-00270

Cited by 8 publications

(5 citation statements)

References 8 publications

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“…10 The original CryoPen (developed for use in high-income medical settings) has been adapted for use in LMICs through modifications that improve portability, durability, and affordability. 11 The LMIC-adapted CryoPen consists of a Stirling cooler built into a toolbox-sized carrying case and an adjoining cryoprobe. The entire device weighs 20 lb, can be carried by hand, and is capable of treating approximately 24 women in an 8-hour day.…”

Section: Review Of Current and Emergent Ablative Technologiesmentioning

confidence: 99%

Ablative Therapies for Cervical Intraepithelial Neoplasia in Low-Resource Settings: Findings and Key Questions

Cremer¹,

Conzuelo-Rodriguez²,

Cherniak³

et al. 2018

JGO

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Barriers to access for cervical precancer care in low-resource settings go beyond cost. Gas-based cryotherapy has emerged as the standard treatment in these areas, but there are barriers to this technology that have necessitated the development and implementation of affordable and portable alternatives. This review identifies knowledge gaps with regard to technologies primarily used in low-resource settings, including standard cryotherapy, nongas-based cryotherapy, and thermoablation. These gaps are addressed using evidence-based guidelines, patient and provider acceptability, long-term obstetric outcomes, and treatment of women with HIV infection. This review highlights the need for prospective studies that compare ablative methods, especially given the increasing use of thermoablation.

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Section: Review Of Current and Emergent Ablative Technologiesmentioning

confidence: 99%

Ablative Therapies for Cervical Intraepithelial Neoplasia in Low-Resource Settings: Findings and Key Questions

Cremer¹,

Conzuelo-Rodriguez²,

Cherniak³

et al. 2018

JGO

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“…Results from previous studies show that nurses are able to master the numerous steps involved in a See and Treat program, including recruitment, education, and performance of clinical exams and treatment [12]. While the See and Treat method is the best option for many settings, there are limitations, including procuring and transporting cryotherapy machines and gas tanks, refilling tanks, and repairing damaged cryotherapy machines [13].…”

Section: Introductionmentioning

confidence: 99%

Cervical Cancer Screening in HIV-Positive Farmers in South Africa: Mixed-Method Assessment

Lieber

Afzal

Shaia

et al. 2019

Annals of Global Health

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Background: In 2015, a See and Treat cervical cancer screening program was implemented at a local HIV clinic in Limpopo, South Africa, where infrastructure limited adequate Pap smear usability. Objectives: The purpose of this evaluation was to determine the quality and sustainability of the implemented program. Methods: A mixed-methods program analysis was conducted at 18-months post implementation. Data collection techniques included in-depth interviews of staff and patients, observation of healthcare workers delivering screening, and review of charts and patient logs. Findings: Eighteen in-depth interviews revealed improved cervical cancer screening understanding and awareness. Privacy concerns and negative perceptions of medical care were barriers to screening. Informal observations revealed continued clinical competence among healthcare workers who had been previously trained. Review of charts demonstrated positive correlation between VIA and Pap smear results. In evaluating loss to attrition, about half of the first cohort of patients were lost to follow-up. VIAs and Pap smears were offered on an ongoing basis, and month-over-month change for overlapping four months of programming between 2015 and 2016 showed a 4.4% negative change in number of Pap smears and a 57% negative change in VIAs. Conclusion: Our evaluation reveals successful integration of See and Treat into current clinic services in rural South Africa and increased awareness of cervical cancer among health workers and participants. Program sustainability was challenging to assess as many patients were lost to follow-up, given the migrant and transient population attending this clinic. Acceptance by health workers and patients alike is vital for the long-term impact on cervical cancer incidence in this region.

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“…CryoPen utilizes small amounts of ethanol, but this is inexpensive and more easily available than gas. Bench testing suggests that CryoPen causes comparable depth of necrosis as gas-based cryotherapy 4. Another ablative method, thermoablation (thermocoagulation or cold coagulation), utilizes heat to induce necrosis.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of two alternative ablation treatments for cervical pre-cancer against standard gas-based cryotherapy: a randomized non-inferiority study

Cremer

Alfaro²,

Garai³

et al. 2019

Int J Gynecol Cancer

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IntroductionGas-based cryotherapy is the conventional ablative treatment for cervical pre-cancer in low-income settings, but the use of gas poses significant challenges. We compared the depth of necrosis induced by gas-based cryotherapy with two gas-free alternatives: cryotherapy using CryoPen,and thermoablation.MethodsWe conducted a five-arm randomized non-inferiority trial: double-freeze carbon dioxide (CO2) cryotherapy (referent), single-freeze CO2 cryotherapy, double-freeze CryoPen, single-freeze CryoPen, and thermoablation. Subjects were 130 women scheduled for hysterectomy for indications other than cervical pathology, and thus with healthy cervical tissue available for histological evaluation of depth of necrosis post-surgery. The null hypothesis was rejected (ie, conclude non-inferiority) if the upper bound of the 90% confidence interval (90% CI) for the difference in mean depth of necrosis (referent minus each experimental method) was <1.14 mm. Patient pain during treatment was reported on a scale of 0 (no pain) to 10 (worst pain).ResultsA total of 133 patients were enrolled in the study. The slides from three women were deemed unreadable. One patient was excluded because her hysterectomy was postponed for reasons unrelated to the study, and two patients were excluded because treatment application did not follow the established protocol. For the remaining 127 women, mean depth of necrosis for double-freeze CO2 (referent) was 6.0±1.6 mm. Differences between this and other methods were: single-freeze CO2 = 0.4 mm (90% CI −0.4 to 1.2 mm), double-freeze CryoPen= 0.7 mm (90% CI 0.04 to 1.4 mm), single-freeze CryoPen= 0.5 mm (90% CI −0.2 to 1.2 mm), and thermoablation = 2.6 mm (90% CI 2.0 to 3.1 mm). Mean pain levels were 2.2±1.0 (double-freeze CO2 cryotherapy), 1.8±0.8 (single-freeze CO2 cryotherapy), 2.5±1.4 (double-freeze CryoPen), 2.6±1.4 (single-freeze CryoPen), and 4.1±2.3 (thermoablation).DiscussionCompared with the referent, non-inferiority could not be concluded for other methods. Mean pain scores were low for all treatments. Depth of necrosis is a surrogate for treatment efficacy, but a randomized clinical trial is necessary to establish true cure rates.

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A Non–Gas-Based Cryotherapy System for the Treatment of Cervical Intraepithelial Neoplasia: A Mixed-Methods Approach for Initial Development and Testing

Cited by 8 publications

References 8 publications

Ablative Therapies for Cervical Intraepithelial Neoplasia in Low-Resource Settings: Findings and Key Questions

Ablative Therapies for Cervical Intraepithelial Neoplasia in Low-Resource Settings: Findings and Key Questions

Cervical Cancer Screening in HIV-Positive Farmers in South Africa: Mixed-Method Assessment

Evaluation of two alternative ablation treatments for cervical pre-cancer against standard gas-based cryotherapy: a randomized non-inferiority study

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