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CTRI Number  CTRI/2018/07/015037 [Registered on: 24/07/2018] Trial Registered Prospectively
Last Modified On: 22/01/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   open label non-randomized prospective feasibility research study on human tissues 
Study Design  Other 
Public Title of Study   Testing of prototype radiofrequency electrode by ablation on excised, discarded cervical tissue 
Scientific Title of Study   BiRF-C Tissue Ablation Study 
Trial Acronym  BiTS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinay Rajan 
Designation  Clinical Research Manager  
Affiliation  Regional Clinical Indian Subcontinent 
Address  India Medtronic Pvt Ltd Solitaire Corporate Park Bldg No 12 4th Floor Andheri Ghatkopar Link Road Andheri (e) Mumbai, Maharashtra - 400093

Mumbai
MAHARASHTRA
400093
India 
Phone    
Fax    
Email  vinay.rajan@medtronic.com  
 
Details of Contact Person
Scientific Query  
Name  Vinay Rajan 
Designation  Clinical Research Manager  
Affiliation  Regional Clinical Indian Subcontinent 
Address  India Medtronic Pvt Ltd Solitaire Corporate Park Bldg No 12 4th Floor Andheri Ghatkopar Link Road Andheri (e) Mumbai, Maharashtra - 400093

Mumbai
MAHARASHTRA
400093
India 
Phone    
Fax    
Email  vinay.rajan@medtronic.com  
 
Details of Contact Person
Public Query  
Name  Vinay Rajan 
Designation  Clinical Research Manager  
Affiliation  Regional Clinical Indian Subcontinent 
Address  India Medtronic Pvt Ltd Solitaire Corporate Park Bldg No 12 4th Floor Andheri Ghatkopar Link Road Andheri (e) Mumbai, Maharashtra - 400093

Mumbai
MAHARASHTRA
400093
India 
Phone    
Fax    
Email  vinay.rajan@medtronic.com  
 
Source of Monetary or Material Support  
India Medtronic Pvt Ltd Solitaire Corporate Park, Building No.12,4th Floor, Andheri -Ghatkopar Link Road, Andheri-East Mumbai, Maharashtra 400 093 INDIA 
 
Primary Sponsor  
Name  India Medtronic Pvt Ltd 
Address  Solitaire Corporate Park, Building No.12,4th Floor, Andheri -Ghatkopar Link Road, Andheri-East Mumbai, Maharashtra 400 093 INDIA  
Type of Sponsor  Other [Medical Device Industry] 
 
Details of Secondary Sponsor  
Name  Address 
Medtronic Surgical Innovations  5920 Longbow Drive, A05 B6-2, Boulder, CO, 80301 USA  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjeet Arora  Batra Hospital and Medcial Research Centre  1 Tuglakabad Insitutional Area M B Road new Delhi Clinical Research Department 1st Floor
New Delhi
DELHI 		 911129958747

arora.manjeet@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Scientific Research & Ethical review committee BHMRC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  BiRF-C is a product in research and development. The indication for the product when developed will be cervical dysplasia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  20-60 years of age
Patients undergoing total or radical hysterectomy due to non-malignant disease, during routine clinical care.
The subject or her Legally Authorized Representative (LAR) has been informed about the nature of the study and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements
Study team able to test discarded excised tissues within 5 hours after hysterectomy
 
 
ExclusionCriteria 
Details  Malignancy/cancerous tissue in the uterus
Not willing to consent
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Ablation depth  Within five hours of hysterectomy performed as per routine clinical care 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 Enrollment (India)   14/08/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   This study is being conducted in order to gather inputs for a prototype product. Hence the data will not be published. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Study of ablation depth using new bipolar electrode prototype design (BiRF-C) utilizing Radio Frequency technology in excised human cervix tissue, discarded during routine clinical care

BiRF-C is a product in research and development. The indication for the product when developed will be cervical dysplasia. In the proposed study the device prototype will be used for testing tissue ablation depth in discarded fresh (<5 hours) cervical tissue specimen at different power settings configurations

This study intends to assess the feasibility of a new technology, BiRF-C ablation prototype for cervical tissue ablation. Results will provide inputs to further modify the prototype design and identify the optimum power, ablation duration, form factor and electrical design in the future version(s) of the prototype.

 
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