FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/04/006807 [Registered on: 08/04/2016] Trial Registered Retrospectively
Last Modified On: 12/07/2021
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   Study of the depth of tissue destruction of cervical epithelium using either the Semm thermal coagulator, the Liger thermal coagulator or cryosurgery  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smita Joshi 
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 of Contact Person
Scientific Query
 
Name  Dr Smita Joshi 
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    
Email  smitanjoshi@gmail.com  
 
Details of Contact 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
411001
India 
Phone  9881132506  
Fax    
Email  smitanjoshi@gmail.com  
 
Source of Monetary or Material Support  
Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital Premises, 32 Sassoon Road, Pune 411001 
 
Primary Sponsor  
Name  Hirabai Cowasji Jehangir Medical Research Institute 
Address  Jehangir Hospital Premises, 32 Sassoon Road, Pune 411001 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Smita Joshi  Department of Obstetrics and Gynaecology, Kamla Nehru Hospital,   Mangalwar Peth, Pune 411005
Pune
MAHARASHTRA 
9881132506

smitanjoshi@gmail.com 
Dr Smita Joshi  Department of Preventive Oncology, Hirabai Cowasji Jehangir Medical Research Institute  Jehangir Hospital Premises, 32 Sassoon Road, Pune 411001
Pune
MAHARASHTRA 
9881132506

smitanjoshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of JCDC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Women undergoing routine hysterectomy for a benign condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cold coagulator  Comparison of depth of tissue necrosis by 20,30 and 45 sec application with cold coagulator on the cervix 
Comparator Agent  Cryotherapy   double freeze cryotherapy on the cervix 
Intervention  Thermocoagulator  Comparison of depth of tissue necrosis by 20,30 and 45 sec application with thermocoagulator on the cervix 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Women undergoing hysterectomy for a benign indication  
 
ExclusionCriteria 
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 Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Depth of tissue destruction of the cervix with Semm cold coagulator, Liger thermocoagulator and double freeze technique with cryotherapy  cross-sectional  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/09/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet available 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Cryotherapy is extensively used to treat ectocervical premalignant lesions that occupy less than 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 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 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, 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. 

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 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 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.

 
Close