| CTRI Number |
CTRI/2025/03/082153 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of efficacy and safety of thermal ablation and cryotherapy for symptomatic cervical ectropion |
|
Scientific Title of Study
|
Comparison of efficacy and safety of thermalablation and cryotherapy for symptomatic cervical ectropion |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shruti Gupta |
| Designation |
Junior resident |
| Affiliation |
King Georges medical university Lucknow |
| Address |
Queen Mary hospital department of obstetrics and gynaecology King Georges medical university lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7017526259 |
| Fax |
|
| Email |
sg851997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manjulata Verma |
| Designation |
Additional professor |
| Affiliation |
King Georges medical university Lucknow |
| Address |
Queen Mary hospital department of obstetrics and gynaecology King Georges medical university lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9721250092 |
| Fax |
|
| Email |
gaganmlv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Manjulata Verma |
| Designation |
Additional professor |
| Affiliation |
King Georges medical university Lucknow |
| Address |
Queen Mary hospital department of obstetrics and gynaecology King Georges medical university lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9721250092 |
| Fax |
|
| Email |
gaganmlv@gmail.com |
|
|
Source of Monetary or Material Support
|
| King Georges medical university shahmina road chowk lucknow India pin code 226003 |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Gupta |
| Address |
King Georges medical university shahmina road chowk lucknow India pin code 226003 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shruti Gupta |
King Georges medical university |
King Georges medical university department of obstetrics and gynaecology shahmina road chowk lucknow India pin code 226003
Lucknow
UTTAR PRADESH |
7017526259
sg851997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges medical university Uttar Pradesh institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N86||Erosion and ectropion of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cryotherapy |
Cryotherapy on patients which will be women suffering with symptomatic cervical ectropion in one sitting and assessing the patients after 6 weeks and 6 months follow up |
| Intervention |
Thermal ablation |
Assessing safety and efficacy of thermal ablation on patients which will be women suffering with symptomatic cervical ectropion in one sitting and comparing with cryotherapy at 6 weeks and 6 months follow up |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients of age 20 to 50 years Patients who will be willing for study and symptoms like persistent vaginal discharge bleeding itching |
|
| ExclusionCriteria |
| Details |
Patients not giving consent for study or pregnant females or abnormal cervical cytological screening or abnormal histopthology reports |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic relief and presence of cervical ectropion on per speculum examination |
6 weeks and 6 months after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Persistence of discharge or not presence of pain presence of post coital bleeding recurrence of cervical ectropion on per speculum examination
|
6 weeks 6 months after intervention |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized control study in which comparison of efficacy and safety of thermal ablation and cryotherapy in patients suffering with symptomatic cervical ectropion that is symptoms like continuous discharge per vaginal post coital bleeding pain itching and on per speculum examination cervical ectropion is present will be done Cryotherapy has been usually done in patients suffering with the same whereas Thermalablation has been done for precancerous lesions of cervix In this study thermalablation will be used to treat patients of symptomatic cervical ectropion and will be compared with cryotherapy A liquid based cytology will be done before the procedure and if it is negative for intraepithelial lesions or malignancy of cervix treatment will be given based on randomized alloted group Group A will be given cryotherapy and group B will be given thermal ablation after which results will be assessed after 6 weeks and 6 months follow up of patients for relief of symptoms and persistence of ectropion on per speculum examination
|