Clinical trial · Interventional
Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia [Part II]
Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Globally, cervical cancer is the second most common cancer for women and kills approximately 250,000 women every year, with the annual number of deaths expected to increase to 410,000 by 2030. The majority (88%) of these deaths occur in low- and middle-income countries (LMICs) where screening and prevention services are limited. Prevention of cervical cancer by identification and treatment of cervical cancer precursors is key, since treatment resources for invasive disease are scarce. A cervical cancer screening program cannot be effective unless it is linked with a proven intervention to prevent the development of cervical cancer. The World Health Organization (WHO) recently released the WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention, which recommends a screen-and-treat approach for cervical cancer prevention, with cryotherapy being the first choice of treatment for women who have a positive screen. However, these programs are still slow to be implemented in part due to the current high cost and low efficiency of cryotherapy equipment that is often prone to breaking. Jhpiego, an affiliate of Johns Hopkins University (JHU), has developed a new cryotherapy device, CryoPop, that is one tenth the cost of current equipment while also ten times more efficient. Once proven safe, feasible and effective, CryoPop could save tens of thousands of lives in low- and middle-income countries each year by preventing cervical cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CryoPop | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cervical Cytology
- description
- 100 women with abnormal cervical cytology will receive cryotherapy with the experimental CryoPop device
- interventionNames
- Device: CryoPop
Primary outcomes (1)
- measure
- Efficacy of CryoPop: negative Pap smear and negative biopsy (if performed) on each study participant.
- timeFrame
- 6 months
- description
- The proportion of pap smears and colposcopy/biopsies that are negative (have no dysplasia or cancer) as confirmed by Pap smear and/or biopsy read by 2 or 3 pathologists. If there is discordance between the Pap and biopsy readings, the reading with the greater abnormality will have priority as an endpoint.
Secondary outcomes (1)
- measure
- Safety of CryoPop: Incidences of adverse events documented throughout the study.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: 1. Must be 30-49 years old 2. High-grade squamous intraepithelial lesion of the cervix (CIN 2/3), confirmed on histology 3. Eligible for cryotherapy based on size of lesion (occupies \<75% of cervix) and fully visible on colposcopy or visual inspection with acetic acid (VIA) 4. Willing and able to provide consent. Exclusion Criteria: 1. Menopausal 2. History of hysterectomy 3. Known HIV+ or active cervical infections 4. Lesion occupies \>75% of cervix and/or extends into the endo cervical canal 5. Pregnancy
References
Publications (9)
- BACKGROUNDThomas G. Are we making progress in curing advanced cervical cancer? J Clin Oncol. 2011 May 1;29(13):1654-6. doi: 10.1200/JCO.2010.34.1966. Epub 2011 Mar 28. No abstract available. PMID 21444860
- BACKGROUNDSawaya GF, Grimes DA. New technologies in cervical cytology screening: a word of caution. Obstet Gynecol. 1999 Aug;94(2):307-10. doi: 10.1016/s0029-7844(99)00289-6. PMID 10432148
- BACKGROUNDvan der Graaf Y, Klinkhamer PJ, Vooijs GP. Effect of population screening for cancer of the uterine cervix in Nijmegen, The Netherlands. Prev Med. 1986 Nov;15(6):582-90. doi: 10.1016/0091-7435(86)90063-0. PMID 3797390
- BACKGROUNDSankaranarayanan R, Rajkumar R, Esmy PO, Fayette JM, Shanthakumary S, Frappart L, Thara S, Cherian J. Effectiveness, safety and acceptability of 'see and treat' with cryotherapy by nurses in a cervical screening study in India. Br J Cancer. 2007 Mar 12;96(5):738-43. doi: 10.1038/sj.bjc.6603633. Epub 2007 Feb 20. PMID 17311015
- BACKGROUNDNene BM, Hiremath PS, Kane S, Fayette JM, Shastri SS, Sankaranarayanan R. Effectiveness, safety, and acceptability of cryotherapy by midwives for cervical intraepithelial neoplasia in Maharashtra, India. Int J Gynaecol Obstet. 2008 Dec;103(3):232-6. doi: 10.1016/j.ijgo.2008.07.016. Epub 2008 Sep 24. PMID 18817909
- BACKGROUNDSauvaget C, Muwonge R, Sankaranarayanan R. Meta-analysis of the effectiveness of cryotherapy in the treatment of cervical intraepithelial neoplasia. Int J Gynaecol Obstet. 2013 Mar;120(3):218-23. doi: 10.1016/j.ijgo.2012.10.014. Epub 2012 Dec 22. PMID 23265830
- BACKGROUNDSantesso N, Mustafa RA, Wiercioch W, Kehar R, Gandhi S, Chen Y, Cheung A, Hopkins J, Khatib R, Ma B, Mustafa AA, Lloyd N, Wu D, Broutet N, Schunemann HJ. Systematic reviews and meta-analyses of benefits and harms of cryotherapy, LEEP, and cold knife conization to treat cervical intraepithelial neoplasia. Int J Gynaecol Obstet. 2016 Mar;132(3):266-71. doi: 10.1016/j.ijgo.2015.07.026. Epub 2015 Nov 28.