CTRI Trial Data Wisap

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CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Fri, 15 Jan 2021 06:09:28 GMT)
CTRI Number CTRI/2016/04/006807 [Registered on: 08/04/2016] - Trial Registered Retrospectively

Last Modified On 22/07/2016
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Other (Specify) [Exploratory study to compare depth of tissue destruction using 3 different ablative
methods]
Study Design Non-randomized, Multiple Arm Trial
Public Title of Study Study of depth of tissue destruction with different treatment options for the treatment of cervical
pre-cancer
Scientific Title of Study of the depth of tissue destruction of cervical epithelium using either the Semm thermal
Study coagulator, the Liger thermal coagulator or cryosurgery
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name Dr Smita Joshi
Trial Coordinator
(multi-center study) Designation Asst Professor
Affiliation
Address Hirabai Cowasji Jehangir Medical Research Institute, Jehangir
Hospital Premises, 32 Sassoon Road, Pune
Pune
MAHARASHTRA
411001
India
Phone 9881132506
Fax
Email smitanjoshi@gmail.com
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Dr Smita Joshi
Query)
Designation Asst Professor
Affiliation Asst Professor
Address Hirabai Cowasji Jehangir Medical Research Institute Hirabai Cowasji
Jehangir Medical Research Institute
Pune
MAHARASHTRA
411001
India
Phone 9881132506
Fax
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Dr Smita Joshi
Designation Asst Professor
Affiliation Asst Professor
Address Hirabai Cowasji Jehangir Medical Research Institute, Jehangir
Hospital Premises, 32 Sassoon Road, Pune Hirabai Cowasji
Jehangir Medical Research Institute, Jehangir Hospital Premises, 32
Sassoon Road, Pune
Pune
MAHARASHTRA
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411001
India
Phone 9881132506
Fax
Source of Monetary or Source of Monetary or Material Support
Material Support
> Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital Premises, 32 Sassoon
Road, Pune 411001
Primary Sponsor Primary Sponsor Details
Name Hirabai Cowasji Jehangir Medical Research Institute
Address Jehangir Hospital Premises, 32 Sassoon Road, Pune 411001
Type of Sponsor Research institution
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr Smita Joshi Department of Mangalwar Peth, Pune 9881132506
Obstetrics and 411005
Gynaecology, Kamla Pune smitanjoshi@gmail.com
Nehru Hospital, MAHARASHTRA
Dr Smita Joshi Department of Jehangir Hospital 9881132506
Preventive Oncology, Premises, 32 Sassoon
Hirabai Cowasji Road, Pune 411001 smitanjoshi@gmail.com
Jehangir Medical Pune
Research Institute MAHARASHTRA
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Ethics Committee of Approved 28/08/2015 Yes
JCDC
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients Women undergoing routine hysterectomy for a
benign condition
Intervention / Type Name Details
Comparator Agent
Intervention Cold coagulator Comparison of depth of tissue
necrosis by 20,30 and 45 sec
application with cold coagulator
on the cervix
Intervention Thermocoagulator Comparison of depth of tissue
necrosis by 20,30 and 45 sec
application with
thermocoagulator on the cervix
Comparator Agent Cryotherapy double freeze cryotherapy on
the cervix
Inclusion Criteria Inclusion Criteria
Age From 18.00 Year(s)
Age To 50.00 Year(s)
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Gender Female
Details Women undergoing hysterectomy for a benign indication
Exclusion Criteria Exclusion Criteria
Details i. Any woman who, for any reason, is not willing to participate
ii. Any woman with a history of abnormal screening test or cervical

disease
iii. Any woman whose cervix would need to be examined

histologically other than routinely
iv. Any women in whom the cervix cannot be exposed adequately
Method of Generating Not Applicable

Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome Timepoints
Depth of tissue destruction of the cervix with cross-sectional
Semm cold coagulator, Liger thermocoagulator
and double freeze technique with cryotherapy
Secondary Outcome Outcome Timepoints
NA NA
Target Sample Size Total Sample Size=21
Sample Size from India=21
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials
Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials
Phase of Trial N/A
Date of First 14/09/2015
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=0
Days=0
Recruitment Status of Closed to Recruitment of Participants
Trial (Global)
Recruitment Status of Closed to Recruitment of Participants
Trial (India)
Publication Details Not yet available
Brief Summary
Cryotherapy is extensively used to treat ectocervical premalignant lesions that occupy less than
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75% of cervix and can be covered by the cryo-probe. For low- and middle-income countries (LMIC)
the World Health Organization (WHO) recommends that cryotherapy be used to treat women
positive on screening tests (HPV Test or Visual Inspection with Acetic Acid (VIA)), even without
colposcopic or histologic verification of disease. This ‘single visit approach’ will significantly
increase the demand for cryotherapy in these countries. Unfortunately, cryotherapy has certain
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logistic disadvantages that can limit its use, such as procuring refrigerant gas, essential for the
technique, or ensuring its regular supply is a major problem in many LMICs. Transporting heavy
tanks of gas is inconvenient and sometimes impossible in remote areas. The blockage of the
nozzle, due to impurities, leakage of gas, etc., are other possible technical difficulties with the
procedure. For this reason, it is essential to find an alternative to cryotherapy that will be suitable
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and sustainable for LMICs. Thermal coagulation, using a portable thermal coagulator, destroys the
transformation zone at temperatures in the 100 to 120oC range. Thermal coagulation was popular in
some regions (especially Scotland in the UK) in the 1970s where very high success rates were
documented in several long-term studies using the SemmTM coagulator (WISAP Medical
Technology, Germany). The technique is as simple as cryotherapy, is an outpatient procedure,
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easily learned and may be performed by a range of providers including nurses. No refrigerant gas is
required and multiple applications of the probe are possible to treat large lesions. In a recent review,
the effectiveness of cold coagulation to treat high-grade lesions was observed to be even better
than cryotherapy.
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LigerTM Medical, USA has developed a novel thermal coagulator for the treatment of cervical
precancers, which has design advantages over the Semm coagulator. Briefly, it is a hand held,
lightweight, inexpensive, battery operated, cordless device, which can perform at least 30
procedures with a single fully charged and rechargeable battery. It is likely to be suitable for
programmes of cervical cancer prevention in LMICs. Preliminary in vitro studies by the
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manufacturers suggest that it reaches the needed temperature quicker than the Semm’s
coagulator, maintains the preset temperature more consistently than the Semm model, achieves a
similar depth of destruction and does not produce smoke nor stick to the tissue post-treatment.
Our proposed study intends to assess the depth of tissue destruction achieved by 20, 30 and 45
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seconds application of thermal ablation (by both the Semm’s and Liger’s coagulators) in the
cervical transformation zone epithelium. This will be done in women who are listed for a
hysterectomy for benign reasons. The depth of tissue destruction achieved by the thermal ablation
equipment will be compared to that achieved by double-freeze cryotherapy – the standard of care.
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CTRI Website URL - http://ctri.nic.in

CTRI Number CTRI/2016/04/006807 [Registered on: 08/04/2016] - Trial Registered Retrospectively

ii. Any woman with a history of abnormal screening test or cervical

iii. Any woman whose cervix would need to be examined

iv. Any women in whom the cervix cannot be exposed adequately

Method of Generating Not Applicable

Technology, Germany). The technique is as simple as cryotherapy, is an outpatient procedure,

programmes of cervical cancer prevention in LMICs. Preliminary in vitro studies by the

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