Cervical Intraepithelial NeoplasiaCryoPenNCT02814448
An Innovative Treatment for Cervical Pre Cancer
A study testing CryoPen, CO2 standard cryotherapy and Thermocoagulator in people with Cervical Intraepithelial Neoplasia, run by The Cleveland Clinic at 2 sites in 2 countries.
Trial summary
The purpose of this study is to test two innovative devices, the CryoPen® and thermocoagulator, against gas-based cryotherapy to determine whether the novel devices produce equivalent or improved destruction of cervical tissue compared to gas-based cryotherapy. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- CryoPen, CO2 standard cryotherapy and Thermocoagulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 25 and 65 years old.
- Scheduled for a hysterectomy for reasons other than cervical precancer or cancer
- Diagnosis of uterine, endometrial, ovarian or other cancer that does not jeopardize the tissue of the cervix is permitted
- Histological evaluation of the cervix does not interfere with the woman's current diagnosis
- Woman consents to participate after being informed about the study
- Normal Pap Smear or HPV test in the past 3 years
Who cannot join
- Pregnancy
- History of cervical surgery in past 5 years
- Presence of cervical lesion pre-invasive or invasive on the cervix *
- Current Pelvic Inflammatory Disorder or severe acute cervicitis
- Cervix shape disfigured or hard to reach
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
El Salvador1 site
Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social
San Salvador
About this study
Official title: CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings
The purpose of this study is to test two innovative devices, the CryoPen® and thermocoagulator, against gas-based cryotherapy to determine whether the novel devices produce equivalent or improved destruction of cervical tissue compared to gas-based cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the CryoPen and gas-based cryotherapy will also be compared.
Read the detailed description
The primary objectives of the study are to test the hypothesis that the CryoPen® and thermocoagulator provide a non-inferior depth of cervical tissue necrosis compared with traditional CO2-based cryotherapy and to test single versus double freeze applications. The secondary objectives of the study are to determine if the CryoPen® or thermocoagulator achieves a depth of necrosis of 3.5 mm, the accepted depth required for eradicating 95% of cervical precancer, and to observe the relationship between depth of necrosis and variations in cervical anatomy.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- CryoPen, CO2 standard cryotherapy, Thermocoagulator
- 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.
CryoPenDevice
Provides a means of freezing tissue without the use of gases or liquids
CO2 standard cryotherapyDevice
Standard therapy using carbon dioxide for freezing of tissue
ThermocoagulatorDevice
The use of heat produced by high-frequency electric current to bring about local destruction of tissues
| Study group | Role | What they receive |
|---|---|---|
| CO2 standard cryotherapy- double freeze | Active comparator | Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze Receives: Device: CO2 standard cryotherapy |
| CO2 standard cryotherapy- single freeze | Active comparator | Single freeze treatment consists of one five-minute freeze Receives: Device: CO2 standard cryotherapy |
| CryoPen- double freeze | Active comparator | Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze Receives: Device: CryoPen |
| CryoPen- single freeze | Active comparator | Single freeze treatment consists of one five-minute freeze Receives: Device: CryoPen |
| Thermocoagulator | Experimental | Single heat application at 100 ºC for 40 seconds Receives: Device: Thermocoagulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy
Measured: 24-48 hours after treatment
Secondary outcomes (1)
Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation
Scale Title: Pain scale during treatment Minimal value = 0 (no pain) Maximum value = 10 (most pain) This is a one item 11-point scale to measure self-reported pain during each of the treatments which lasted between 40 seconds (thermoablation) and 13 minutes (double freeze cryotherapy and double freeze CryoPen).
Measured: 40 seconds to 13 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Basic Health International, Inc., CryoPen, Inc., University of Southern California, Albert Einstein College of Medicine
- Responsible party
- Sponsor
- Investigators
- Miriam Cremer, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814448
- Sponsor's protocol ID
- 15-296
- Other IDs
- UH2CA189883
- Acronym
- CryoPen
- Status last verified
- Oct 2018
- First submitted
- 13 Jun 2016
- Last updated
- 20 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings
- ClinicalTrials.gov ID
- NCT02814448
- Acronym / sponsor ID
- CryoPen / 15-296
- Conditions
- Cervical Intraepithelial Neoplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Basic Health International, Inc., CryoPen, Inc., University of Southern California, Albert Einstein College of Medicine
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Posted 20 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test two innovative devices, the CryoPen® and thermocoagulator, against gas-based cryotherapy to determine whether the novel devices produce equivalent or improved destruction of cervical tissue compared to gas-based cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the CryoPen and gas-based cryotherapy will also be compared.
Detailed description
The primary objectives of the study are to test the hypothesis that the CryoPen® and thermocoagulator provide a non-inferior depth of cervical tissue necrosis compared with traditional CO2-based cryotherapy and to test single versus double freeze applications. The secondary objectives of the study are to determine if the CryoPen® or thermocoagulator achieves a depth of necrosis of 3.5 mm, the accepted depth required for eradicating 95% of cervical precancer, and to observe the relationship between depth of necrosis and variations in cervical anatomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CO2 standard cryotherapy- double freeze | Active comparator | Device: CO2 standard cryotherapyDouble freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze |
| CO2 standard cryotherapy- single freeze | Active comparator | Device: CO2 standard cryotherapySingle freeze treatment consists of one five-minute freeze |
| CryoPen- double freeze | Active comparator | Device: CryoPenDouble freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze |
| CryoPen- single freeze | Active comparator | Device: CryoPenSingle freeze treatment consists of one five-minute freeze |
| Thermocoagulator | Experimental | Device: ThermocoagulatorSingle heat application at 100 ºC for 40 seconds |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 25 and 65 years old.
- Scheduled for a hysterectomy for reasons other than cervical precancer or cancer
- Diagnosis of uterine, endometrial, ovarian or other cancer that does not jeopardize the tissue of the cervix is permitted
- Histological evaluation of the cervix does not interfere with the woman's current diagnosis
- Woman consents to participate after being informed about the study
Key exclusion criteria (5 listed)
- Pregnancy
- History of cervical surgery in past 5 years
- Presence of cervical lesion pre-invasive or invasive on the cervix *
- Current Pelvic Inflammatory Disorder or severe acute cervicitis
- Cervix shape disfigured or hard to reach
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 |
|---|---|---|
| CryoPenProvides a means of freezing tissue without the use of gases or liquids | Device | CryoPen- double freeze, CryoPen- single freeze |
| CO2 standard cryotherapyStandard therapy using carbon dioxide for freezing of tissue | Device | CO2 standard cryotherapy- double freeze, CO2 standard cryotherapy- single freeze |
| ThermocoagulatorThe use of heat produced by high-frequency electric current to bring about local destruction of tissues | Device | Thermocoagulator |
Primary outcome
Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy
Time frame: 24-48 hours after treatment
1 secondary outcome
Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation
Time frame: 40 seconds to 13 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cervical Intraepithelial Neoplasia
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
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.
Miriam Cremer, MD principal investigator
The Cleveland Clinic
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CryoPen, CO2 standard cryotherapy and Thermocoagulator in people with Cervical Intraepithelial Neoplasia, run by The Cleveland Clinic at 2 sites in 2 countries.
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 6 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in El Salvador, Peru. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy (time frame: 24-48 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2018.