Cervical PrecancerDELTANCT02956239
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
A study testing Thermocoagulation (device), Cryotherapy (device) and LEEP (device) in people with Cervical Precancer, run by International Agency for Research on Cancer at 1 site in Zambia.
Trial summary
This project develops, tests and produces a lightweight, cordless, battery driven and rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The study evaluates its effectiveness compared to the current standard treatment (cryocautery) when used as part of a screen and treat… Read more about this study
- Who is it for?
- Ages 25 to 49 years, women only
- Conditions the study is for
- Cervical Precancer
- What is being tested?
- Thermocoagulation (device), Cryotherapy (device) and LEEP (device)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,124 participants
- Where
- 1 siteZambia
- Study dates
- 1 Aug 2017to 29 Feb 2024
- 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 25 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Positive on VIA test for cervical cancer screening
- Eligible for ablative treatment
Who cannot join
- Pregnancy
- Not voluntarily willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
This project develops, tests and produces a lightweight, cordless, battery driven and rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The study evaluates 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.
Read the 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
- To develop, test and produce 20 novel lightweight hand-held cordless, portable battery driven and rechargeable Thermal Coagulators (Liger Medical, Utah).
- 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.
- To evaluate the user satisfaction scores of the Liger Thermal Coagulator cryocautery as part of a screen and treat programme in Zambia.
- To determine the rate of over treatment of VIA positive women as revealed by histopathological examination of the randomly assigned excised treatment cases.
- 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 has been developed and tested in vitro and in vivo. 200+ Liger units have been produced and a randomised controlled trial of the device has been undertaken, compared to cryocautery and LLETZ using efficacy and user friendliness as endpoints. The inclusion of a study arm of excisional therapy allows 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.
- Conditions
- Cervical Precancer
- Being tested
- Thermocoagulation (device), Cryotherapy (device), LEEP (device)
- Keywords
- cervical precancer, screening, treatment, thermo-coagulation, thermal ablation, Reducing overtreatment
- 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.
Thermocoagulation (device)Procedure or surgery
Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix
Cryotherapy (device)Procedure or surgery
Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix
LEEP (device)Procedure or surgery
The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit
| Study group | Role | What they receive |
|---|---|---|
| Thermocoagulation (device) | Experimental | VIA Positive women will be treated by the new device for thermocoagulation Receives: Procedure: Thermocoagulation (device) |
| Cryotherapy (device) | Active comparator | VIA positive women will be treated by cryotherapy Receives: Procedure: Cryotherapy (device) |
| LEEP (device) | Active comparator | VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP Receives: Procedure: LEEP (device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportions with no lesions at 12 months follow-up between the thermocoagulation and cryotherapy arms among VIA positive women treated at baseline
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
Measured: 12 months
Secondary outcomes (1)
Over-treatment defined as the number of VIA positive women found with no CIN lesions in the post-operative LEEP specimens
The LEEP specimens will be subjected to histopathology to check for presence of cervical intraepithelial neoplasias
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start1 Aug 2017
- Primary completion16 Feb 2022
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical PrecancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,124 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina Global Project Zambia, Liger Medical Llc
- Responsible party
- Principal investigator, Partha Basu, International Agency for Research on Cancer
- Investigators
- Partha Basu, Dr, Principal investigator, IARC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956239
- Sponsor's protocol ID
- 1UH2CA202721-01
- Acronym
- DELTA
- Status last verified
- Jul 2024
- First submitted
- 6 Sep 2016
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Pinder LF, Parham GP, Basu P, Muwonge R, Lucas E, Nyambe N, Sauvaget C, Mwanahamuntu MH, Sankaranarayanan R, Prendiville W. Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial. Lancet Oncol. 2020 Jan;21(1):175-184. doi: 10.1016/S1470-2045(19)30635-7. Epub 2019 Nov 14.
PubMed 31734069Mwanahamuntu M, Kapambwe S, Pinder LF, Matambo J, Chirwa S, Chisele S, Basu P, Prendiville W, Sankaranarayanan R, Parham GP. The use of thermal ablation in diverse cervical cancer "screen-and-treat" service platforms in Zambia. Int J Gynaecol Obstet. 2022 Apr;157(1):85-89. doi: 10.1002/ijgo.13808. Epub 2021 Jul 31.
PubMed 34197624Basu P, Mwanahamuntu M, Pinder LF, Muwonge R, Lucas E, Nyambe N, Chisele S, Shibemba AL, Sauvaget C, Sankaranarayanan R, Prendiville W, Parham GP. A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial. Nat Med. 2024 Sep;30(9):2596-2604. doi: 10.1038/s41591-024-03080-w. Epub 2024 Jun 25.
PubMed 38918630
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02956239
- Acronym / sponsor ID
- DELTA / 1UH2CA202721-01
- Conditions
- Cervical Precancer
- Keywords
- cervical precancer, screening, treatment, thermo-coagulation, thermal ablation, Reducing overtreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,124 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- University of North Carolina Global Project Zambia, Liger Medical Llc
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 7 Nov 2016 (estimated)
- 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.
This project develops, tests and produces a lightweight, cordless, battery driven and rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The study evaluates 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.
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
- To develop, test and produce 20 novel lightweight hand-held cordless, portable battery driven and rechargeable Thermal Coagulators (Liger Medical, Utah).
- 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.
- To evaluate the user satisfaction scores of the Liger Thermal Coagulator cryocautery as part of a screen and treat programme in Zambia.
- To determine the rate of over treatment of VIA positive women as revealed by histopathological examination of the randomly assigned excised treatment cases.
- 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 has been developed and tested in vitro and in vivo. 200+ Liger units have been produced and a randomised controlled trial of the device has been undertaken, compared to cryocautery and LLETZ using efficacy and user friendliness as endpoints. The inclusion of a study arm of excisional therapy allows 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thermocoagulation (device) | Experimental | Procedure: Thermocoagulation (device)VIA Positive women will be treated by the new device for thermocoagulation |
| Cryotherapy (device) | Active comparator | Procedure: Cryotherapy (device)VIA positive women will be treated by cryotherapy |
| LEEP (device) | Active comparator | Procedure: LEEP (device)VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Positive on VIA test for cervical cancer screening
- Eligible for ablative treatment
Key exclusion criteria (2 listed)
- Pregnancy
- Not voluntarily willing to participate
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 |
|---|---|---|
| Thermocoagulation (device)Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix | Procedure or surgery | Thermocoagulation (device) |
| Cryotherapy (device)Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix | Procedure or surgery | Cryotherapy (device) |
| LEEP (device)The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit | Procedure or surgery | LEEP (device) |
Primary outcome
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
1 secondary outcome
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
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 8 Jul 2024.
- Background: PubMed 31734069Pinder LF, Parham GP, Basu P, Muwonge R, Lucas E, Nyambe N, Sauvaget C, Mwanahamuntu MH, Sankaranarayanan R, Prendiville W. Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial. Lancet Oncol. 2020 Jan;21(1):175-184. doi: 10.1016/S1470-2045(19)30635-7. Epub 2019 Nov 14.
- Background: PubMed 34197624Mwanahamuntu M, Kapambwe S, Pinder LF, Matambo J, Chirwa S, Chisele S, Basu P, Prendiville W, Sankaranarayanan R, Parham GP. The use of thermal ablation in diverse cervical cancer "screen-and-treat" service platforms in Zambia. Int J Gynaecol Obstet. 2022 Apr;157(1):85-89. doi: 10.1002/ijgo.13808. Epub 2021 Jul 31.
- Background: PubMed 38918630Basu P, Mwanahamuntu M, Pinder LF, Muwonge R, Lucas E, Nyambe N, Chisele S, Shibemba AL, Sauvaget C, Sankaranarayanan R, Prendiville W, Parham GP. A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial. Nat Med. 2024 Sep;30(9):2596-2604. doi: 10.1038/s41591-024-03080-w. Epub 2024 Jun 25.
- Individual participant dataSharing planned: Yes
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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.
Partha Basu, Dr principal investigator
IARC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermocoagulation (device), Cryotherapy (device) and LEEP (device) in people with Cervical Precancer, run by International Agency for Research on Cancer at 1 site in Zambia.
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 2 inclusion and 2 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 8 Jul 2024. 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 Zambia. 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?
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). 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 NCT02956239, which also lists 3 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 8 Jul 2024.