| 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
|
|
|
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
|
|
|
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
|
|
|
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. |