NCT02814448

Brief 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. Tissue destruction with single freeze versus double freeze treatments with the CryoPen and gas-based cryotherapy will also be compared.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 20, 2018

Completed
Last Updated

November 20, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

June 13, 2016

Results QC Date

April 23, 2018

Last Update Submit

October 22, 2018

Conditions

Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

  • Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy

    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

    40 seconds to 13 minutes

Study Arms (5)

CO2 standard cryotherapy- double freeze

ACTIVE COMPARATOR

Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze

Device: CO2 standard cryotherapy

CO2 standard cryotherapy- single freeze

ACTIVE COMPARATOR

Single freeze treatment consists of one five-minute freeze

Device: CO2 standard cryotherapy

CryoPen- double freeze

ACTIVE COMPARATOR

Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze

Device: CryoPen

CryoPen- single freeze

ACTIVE COMPARATOR

Single freeze treatment consists of one five-minute freeze

Device: CryoPen

Thermocoagulator

EXPERIMENTAL

Single heat application at 100 ºC for 40 seconds

Device: Thermocoagulator

Interventions

CryoPenDEVICE

Provides a means of freezing tissue without the use of gases or liquids

CryoPen- double freezeCryoPen- single freeze
CO2 standard cryotherapyDEVICE

Standard therapy using carbon dioxide for freezing of tissue

CO2 standard cryotherapy- double freezeCO2 standard cryotherapy- single freeze
ThermocoagulatorDEVICE

The use of heat produced by high-frequency electric current to bring about local destruction of tissues

Thermocoagulator

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social

San Salvador, El Salvador

Location

Instituto Nacional de Enfermedades Neoplásicas

Lima, Peru

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
Dr. Miriam Cremer
Organization
Cleveland Clinic
cremerm@ccf.org
216-312-0618

Study Officials

  • Miriam Cremer, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 27, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 20, 2018

Results First Posted

November 20, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

EL(1)PE(1)