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Development, Field Testing and Evaluation of the Efficacy of a Hand-held, Portable and Affordable Thermo-coagulator to Prevent Cervical Cancer in Low- and Middle-income Countries (DELTA)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified November 2016 by Dr R. Sankaranarayanan, International Agency for Research on Cancer
Sponsor:
Collaborators:
University of North Carolina Global Project Zambia
Liger Medical Llc
Information provided by (Responsible Party):
Dr R. Sankaranarayanan, International Agency for Research on Cancer
ClinicalTrials.gov Identifier:
NCT02956239
First received: September 6, 2016
Last updated: November 4, 2016
Last verified: November 2016
  Purpose
This project will develop, test and produce a lightweight, cordless, battery driven and rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The study will evaluate its effectiveness compared to the current standard treatment (cryocautery) when used as part of a screen and treat programme using Visual Inspection with Acetic acid (VIA) in Sub Saharan Africa.

Condition Intervention
Cervical Precancer Procedure: Thermocoagulation (device) Procedure: Cryotherapy (device) Procedure: LEEP (device)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development, Field Testing and Evaluation of the Efficacy of a Hand-held, Portable and Affordable Thermo-coagulator to Prevent Cervical Cancer in Low- and Middle-income Countries

Resource links provided by NLM:


Further study details as provided by Dr R. Sankaranarayanan, International Agency for Research on Cancer:

Primary Outcome Measures:
  • Difference in proportions with no lesions at 12 months follow-up between the thermocoagulation and cryotherapy arms among VIA positive women treated at baseline [ Time Frame: 12 months ]
    The VIA positive women will be followed up after 12 months to see if the lesions have disappeared. HPV test will be used as the test of cure


Secondary Outcome Measures:
  • Over-treatment defined as the number of VIA positive women found with no CIN lesions in the post-operative LEEP specimens [ Time Frame: 12 months ]
    The LEEP specimens will be subjected to histopathology to check for presence of cervical intraepithelial neoplasias


Estimated Enrollment: 450
Study Start Date: February 2017
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thermocoagulation (device)
VIA Positive women will be treated by the new device for thermocoagulation
Procedure: Thermocoagulation (device)
Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix
Active Comparator: Cryotherapy (device)
VIA positive women will be treated by cryotherapy
Procedure: Cryotherapy (device)
Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix
Active Comparator: LEEP (device)
VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP
Procedure: LEEP (device)
The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit

Detailed Description:

This project aims to improve screen and treat programmes for cervical cancers by discovering the best method of treatment. The specific aims are

  1. To develop, test and produce 20 novel lightweight hand-held cordless, portable battery driven and rechargeable Thermal Coagulators (Liger Medical, Utah).
  2. To evaluate the success / failure rate of Thermal Coagulation in a randomised controlled trial comparing thermal coagulation to the existing current standard cryocautery and to Large Loop Excision of the Transformation Zone (LLETZ aka LEEP) as part of a screen and treat programme in Zambia.
  3. To evaluate the user satisfaction scores of the Liger Thermal Coagulator cryocautery as part of a screen and treat programme in Zambia.
  4. To determine the rate of over treatment of VIA positive women as revealed by histopathological examination of the randomly assigned excised treatment cases.
  5. To determine the value of Z scan to predict normality and abnormality in VIA positive women randomly assigned to excisional therapy

In collaboration with a medical devices company in Utah, the engineering performance of the Liger Thermal Coagulator will be developed and tested in vitro and in vivo. 200+ Liger units will be produced and a randomised controlled trial of the device will be undertaken, compared to cryocautery and LLETZ using efficacy and user friendliness as endpoints. The inclusion of a study arm of excisional therapy will allow to quantify the rate of overtreatment in VIA programmes and using the Z scan may allow for a non invasive method of accurately predicting normality and abnormality in VIA positive women.

  Eligibility

Ages Eligible for Study:   25 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive on VIA test for cervical cancer screening
  • Eligible for ablative treatment

Exclusion Criteria:

  • Pregnancy
  • Not voluntaily willing to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02956239

Contacts
Contact: Rengaswamy Sankaranarayanan, Dr 0472738485 ext 8674 SankarR@iarc.fr
Contact: Partha Basu, Dr 0472738485 ext 8674 BasuP@iarc.fr

Sponsors and Collaborators
International Agency for Research on Cancer
University of North Carolina Global Project Zambia
Liger Medical Llc
Investigators
Principal Investigator: Rengaswamy Sankaranarayanan IARC
  More Information

Responsible Party: Dr R. Sankaranarayanan, Head of the Screening Group at IARC, WHO, International Agency for Research on Cancer
ClinicalTrials.gov Identifier: NCT02956239     History of Changes
Other Study ID Numbers: 1UH2CA202721-01 ( U.S. NIH Grant/Contract )
Study First Received: September 6, 2016
Last Updated: November 4, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Dr R. Sankaranarayanan, International Agency for Research on Cancer:
cervical precancer
screening
treatment
thermo-coagulation
thermal ablation
Reducing overtreatment

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions

ClinicalTrials.gov processed this record on September 21, 2017