Cervical DysplasiaCryoPopNCT04154644
Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia [Part II]
A study testing CryoPop in people with Cervical Dysplasia, run by Jhpiego at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 49 years, women only
- Conditions the study is for
- Cervical Dysplasia
- What is being tested?
- CryoPop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- 9 Apr 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Must be 30-49 years old
- High-grade squamous intraepithelial lesion of the cervix (CIN 2/3), confirmed on histology
- Eligible for cryotherapy based on size of lesion (occupies <75% of cervix) and fully visible on colposcopy or visual inspection with acetic acid (VIA)
- Willing and able to provide consent.
Who cannot join
- Menopausal
- History of hysterectomy
- Known HIV+ or active cervical infections
- Lesion occupies >75% of cervix and/or extends into the endo cervical canal
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia
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.
Read the detailed description
The World Health Organization (WHO) Guidelines for screening and treatment of precancerous lesions for cervical cancer prevention 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. Cryotherapy using nitrous oxide (N2O) or carbon dioxide (CO2) to induce cryonecrosis of dysplastic tissues followed by regeneration of normal cervical epithelium is the most common intervention used in LMICs because it is simple and safe enough for competently-trained mid-level providers such as nurses and midwives to operate, and can be performed without anesthesia or electricity. Adverse effects after cryotherapy are relatively uncommon and generally minor, reported in 1-2% of women. A recent meta-analysis of 77 studies (with moderate to high quality evidence) regarding the effectiveness of cryotherapy found cure rates of 92% and 85%, respectively, in CIN 2 and CIN 3. Cure was defined as normal cytology or disease-free state (generally with colposcopy +/- biopsy) at the follow-up visit, implying absence of persistent disease or recurrent lesions after treatment and length of follow-up varied from 3 months to 10 years. A more recent systematic review and meta-analyses of benefits and harms of cryotherapy, as well as Loop Electrosurgical Excision Procedure (LEEP) and cervical conization (167 studies) found a residual/ recurrence rate of cervical dysplasia (CIN 2-3) of 5% at 12 months' follow-up. Major and minor adverse events occurred in less than 1% of women and were fewer with cryotherapy than with the other approaches. Limited data suggests that preterm delivery in subsequent pregnancy may be increased (<2%) with cryotherapy or LEEP.
Cost, reliability, durability, portability and reparability are all factors that prohibit the scale-up necessary for current cryotherapy methods to match the volume of population-based screening needed to achieve a marked decrease in cervical cancer morbidity and mortality. Each cryotherapy unit costs approximately $2,000-$7500, resulting in approximately 80% or more of the treatment cost of cryotherapy being directly attributed to equipment cost. The design involves many custom parts available only through the manufacturers, which are all based in the US or Europe. This prohibits local repairs and limits the life of the product to only one or two years (or even less when spare parts are not available). Additionally, the current technology requires huge amount of N20 or CO2 requiring large gas cylinders which are heavy and costly-the cost to refill a CO2 tank can be up to $200.
The subject of this proposal, CryoPop, is a new technology specifically designed for LMIC settings and more appropriate to support see-and-treat efforts because of its low cost, portability, reparability and durability. The CryoPop device is currently expected to cost one half of the price of current devices while also using one tenth of the CO2 supply, thereby substantially reducing the recurring cost of refilling a smaller and more portable gas supply with far greater efficiency in the use of CO2. Moreover, this device is designed to have minimal moving components which at the same time are inexpensive to replace and easy to repair in- situ by the providers themselves. Finally, the CryoPop is not tethered to the gas canister during the procedure, adding more safety to the treatment procedure by not having to be concerned over tank or gas line placement.The goal is to have a device for the frontline where screening is happening and provide the unique opportunity of minimizing if not preventing loss to follow-up of screen-positive women.
This will accelerate access to cervical cancer prevention and treatment services by enabling implementation of single-visit approach (SVA) to rural, underdeveloped regions, most of which have never had cervical cancer prevention (CECAP) programs.
This clinical trial is Part 2 of a 2-part research study. Part 1 of this research study is registered under:
1UH2CA189923-01 Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia NCT02367625
- Conditions
- Cervical Dysplasia
- Being tested
- CryoPop
- Keywords
- Cryotherapy
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoPopDevice
The new CryoPop device will be tested on women with abnormal cytology. Benchmark testing occurred in the previous study and CryoPop was found to be non-inferior to standard cryotherapy device (MedGyn) in woman with normal cytology.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Cytology | Experimental | 100 women with abnormal cervical cytology will receive cryotherapy with the experimental CryoPop device Receives: Device: CryoPop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of CryoPop: negative Pap smear and negative biopsy (if performed) on each study participant.
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.
Measured: 6 months
Secondary outcomes (1)
Safety of CryoPop: Incidences of adverse events documented throughout the study.
Percent of adverse events (AE) and serious adverse events (SAE) will be reported for the study sample. These values will be compared to the safety profile reported for another standard commercially available cryotherapy device.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start9 Apr 2019
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cervical DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College
- Responsible party
- Sponsor
- Investigators
- Jean Anderson, MD, Principal investigator, janders@jhmi.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154644
- Sponsor's protocol ID
- 1UH3CA189923-01
- Acronym
- CryoPop
- Status last verified
- Jan 2022
- First submitted
- 29 Oct 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and research materials will be made available for public access upon the completion of the data collection. This data will be shared through the JHU Data Archive, which uses an established repository platform (Dataverse) and is supported by preservation practices, with administrative help for preparing deposits provided by Johns Hopkins Data Services. Deposited data is given standard data citations and persistent identifiers (DOIs) and will be archived for a minimum of 5 years, with the possibility of renewal.
Publications
Thomas 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.
PubMed 21444860Sawaya 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.
PubMed 10432148van 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.
PubMed 3797390Sankaranarayanan 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.
PubMed 17311015Nene 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.
PubMed 18817909Sauvaget 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.
PubMed 23265830Santesso 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.
PubMed 26643302Quentin W, Adu-Sarkodie Y, Terris-Prestholt F, Legood R, Opoku BK, Mayaud P. Costs of cervical cancer screening and treatment using visual inspection with acetic acid (VIA) and cryotherapy in Ghana: the importance of scale. Trop Med Int Health. 2011 Mar;16(3):379-89. doi: 10.1111/j.1365-3156.2010.02722.x. Epub 2011 Jan 9.
PubMed 21214692Yogeshkumar S, Anderson J, Lu E, Kenyi E, Mensa M, Thaler K, Antartani R, Donimath K, Patil B, Chikaraddi S, Bidri S, Biradar A, Gudadinni MR, Lokare L, Yenokyan G, Bellad MB, Goudar SS, Derman R, Revankar A, Patil H, Wani R, Kangle R, Chavan RY, Nagmoti MB, Kabadi YM, Reddy P, Vernekar S, Hipparagi S, Patil V, Dalal A. Safety and efficacy of the new CryoPop(R) cryotherapy device for cervical dysplasia in low- and middle-income countries: study protocol for a multicenter open-label non-inferiority clinical trial with historical controls. Trials. 2021 Dec 13;22(1):915. doi: 10.1186/s13063-021-05802-8.
PubMed 34903244
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia
- ClinicalTrials.gov ID
- NCT04154644
- Acronym / sponsor ID
- CryoPop / 1UH3CA189923-01
- Conditions
- Cervical Dysplasia
- Keywords
- Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The World Health Organization (WHO) Guidelines for screening and treatment of precancerous lesions for cervical cancer prevention 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. Cryotherapy using nitrous oxide (N2O) or carbon dioxide (CO2) to induce cryonecrosis of dysplastic tissues followed by regeneration of normal cervical epithelium is the most common intervention used in LMICs because it is simple and safe enough for competently-trained mid-level providers such as nurses and midwives to operate, and can be performed without anesthesia or electricity. Adverse effects after cryotherapy are relatively uncommon and generally minor, reported in 1-2% of women. A recent meta-analysis of 77 studies (with moderate to high quality evidence) regarding the effectiveness of cryotherapy found cure rates of 92% and 85%, respectively, in CIN 2 and CIN 3. Cure was defined as normal cytology or disease-free state (generally with colposcopy +/- biopsy) at the follow-up visit, implying absence of persistent disease or recurrent lesions after treatment and length of follow-up varied from 3 months to 10 years. A more recent systematic review and meta-analyses of benefits and harms of cryotherapy, as well as Loop Electrosurgical Excision Procedure (LEEP) and cervical conization (167 studies) found a residual/ recurrence rate of cervical dysplasia (CIN 2-3) of 5% at 12 months' follow-up. Major and minor adverse events occurred in less than 1% of women and were fewer with cryotherapy than with the other approaches. Limited data suggests that preterm delivery in subsequent pregnancy may be increased (<2%) with cryotherapy or LEEP.
Cost, reliability, durability, portability and reparability are all factors that prohibit the scale-up necessary for current cryotherapy methods to match the volume of population-based screening needed to achieve a marked decrease in cervical cancer morbidity and mortality. Each cryotherapy unit costs approximately $2,000-$7500, resulting in approximately 80% or more of the treatment cost of cryotherapy being directly attributed to equipment cost. The design involves many custom parts available only through the manufacturers, which are all based in the US or Europe. This prohibits local repairs and limits the life of the product to only one or two years (or even less when spare parts are not available). Additionally, the current technology requires huge amount of N20 or CO2 requiring large gas cylinders which are heavy and costly-the cost to refill a CO2 tank can be up to $200.
The subject of this proposal, CryoPop, is a new technology specifically designed for LMIC settings and more appropriate to support see-and-treat efforts because of its low cost, portability, reparability and durability. The CryoPop device is currently expected to cost one half of the price of current devices while also using one tenth of the CO2 supply, thereby substantially reducing the recurring cost of refilling a smaller and more portable gas supply with far greater efficiency in the use of CO2. Moreover, this device is designed to have minimal moving components which at the same time are inexpensive to replace and easy to repair in- situ by the providers themselves. Finally, the CryoPop is not tethered to the gas canister during the procedure, adding more safety to the treatment procedure by not having to be concerned over tank or gas line placement.The goal is to have a device for the frontline where screening is happening and provide the unique opportunity of minimizing if not preventing loss to follow-up of screen-positive women.
This will accelerate access to cervical cancer prevention and treatment services by enabling implementation of single-visit approach (SVA) to rural, underdeveloped regions, most of which have never had cervical cancer prevention (CECAP) programs.
This clinical trial is Part 2 of a 2-part research study. Part 1 of this research study is registered under:
1UH2CA189923-01 Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia NCT02367625
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Cytology | Experimental | Device: CryoPop100 women with abnormal cervical cytology will receive cryotherapy with the experimental CryoPop device |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must be 30-49 years old
- High-grade squamous intraepithelial lesion of the cervix (CIN 2/3), confirmed on histology
- Eligible for cryotherapy based on size of lesion (occupies <75% of cervix) and fully visible on colposcopy or visual inspection with acetic acid (VIA)
- Willing and able to provide consent.
Key exclusion criteria (5 listed)
- Menopausal
- History of hysterectomy
- Known HIV+ or active cervical infections
- Lesion occupies >75% of cervix and/or extends into the endo cervical canal
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoPopThe new CryoPop device will be tested on women with abnormal cytology. Benchmark testing occurred in the previous study and CryoPop was found to be non-inferior to standard cryotherapy device (MedGyn) in woman with normal cytology. | Device | Cervical Cytology |
Primary outcome
Efficacy of CryoPop: negative Pap smear and negative biopsy (if performed) on each study participant.
Time frame: 6 months
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.
1 secondary outcome
Safety of CryoPop: Incidences of adverse events documented throughout the study.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Background: PubMed 21444860Thomas 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.
- Background: PubMed 10432148Sawaya 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.
- Background: PubMed 3797390van 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.
- Background: PubMed 17311015Sankaranarayanan 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.
- Background: PubMed 18817909Nene 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.
- Background: PubMed 23265830Sauvaget 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.
- Background: PubMed 26643302Santesso 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.
- Background: PubMed 21214692Quentin W, Adu-Sarkodie Y, Terris-Prestholt F, Legood R, Opoku BK, Mayaud P. Costs of cervical cancer screening and treatment using visual inspection with acetic acid (VIA) and cryotherapy in Ghana: the importance of scale. Trop Med Int Health. 2011 Mar;16(3):379-89. doi: 10.1111/j.1365-3156.2010.02722.x. Epub 2011 Jan 9.
- Derived from this study: PubMed 34903244Yogeshkumar S, Anderson J, Lu E, Kenyi E, Mensa M, Thaler K, Antartani R, Donimath K, Patil B, Chikaraddi S, Bidri S, Biradar A, Gudadinni MR, Lokare L, Yenokyan G, Bellad MB, Goudar SS, Derman R, Revankar A, Patil H, Wani R, Kangle R, Chavan RY, Nagmoti MB, Kabadi YM, Reddy P, Vernekar S, Hipparagi S, Patil V, Dalal A. Safety and efficacy of the new CryoPop(R) cryotherapy device for cervical dysplasia in low- and middle-income countries: study protocol for a multicenter open-label non-inferiority clinical trial with historical controls. Trials. 2021 Dec 13;22(1):915. doi: 10.1186/s13063-021-05802-8.
- WHO guidelines for screening and treatment of precancerous lesions for cervical cancer preventionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data and research materials will be made available for public access upon the completion of the data collection. This data will be shared through the JHU Data Archive, which uses an established repository platform (Dataverse) and is supported by preservation practices, with administrative help for preparing deposits provided by Johns Hopkins Data Services. Deposited data is given standard data citations and persistent identifiers (DOIs) and will be archived for a minimum of 5 years, with the possibility of renewal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Anderson, MD principal investigator
janders@jhmi.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CryoPop in people with Cervical Dysplasia, run by Jhpiego at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of CryoPop: negative Pap smear and negative biopsy (if performed) on each study participant. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154644, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.