| CTRI Number |
CTRI/2025/05/087641 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ablative procedure] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The role of thermalablation in treatment of vaginal discharge |
|
Scientific Title of Study
|
Role of thermal ablation in the management of symptomatic cervical ectropion. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avantika Raina |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research,Chandigarh |
| Address |
Department of obstetrics and gynaecology ,3rd floor nehru block,pgimer,chandigarh, sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9541377809 |
| Fax |
|
| Email |
rainaavantika96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RIMPI SINGLA |
| Designation |
Additional professor obstetrics and gynaecology, pgimer |
| Affiliation |
PGIMER chandigarh |
| Address |
room no 11 3rd floor nehru block
department of obstetrics and gynaecology
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008008 |
| Fax |
|
| Email |
drrimpisingla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avantika Raina |
| Designation |
junior resident department of obstetrics and gynaecology |
| Affiliation |
PGIMER chandigarh |
| Address |
3rd floor nehru PGIMER, department of obstetrics and gynaecology.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9541377809 |
| Fax |
|
| Email |
rainaavantika96@gmail.com |
|
|
Source of Monetary or Material Support
|
| special research grant ,medical education and research cell,PGIMER |
|
|
Primary Sponsor
|
| Name |
medical education and research cellpgimer |
| Address |
sec 12 pgimer chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Avantika Raina |
PGIMER, Chandigarh |
room no 2055 outpatient department of obstetrics and gynaecology, new opd
Chandigarh
CHANDIGARH |
9541377809
rainaavantika96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee pgimer chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N888||Other specified noninflammatory disorders of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
thermal ablation |
thermal ablation will be performed using a WISAP thermoablator. working principle is ablation of lesion by heat. the tip of ablator is placed at ectropion area for 30-40 secs. It ablates the abnormal area. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Multiparous
Cervical ectropion on per speculum examination
Persistent or recurrent vaginal discharge
Normal cervical cancer screening test
Normal or inflammatory cervical cytology
Willing to participate
|
|
| ExclusionCriteria |
| Details |
Unmarried Nulliparous women
Postmenopausal women
Abnormal screening test (cytology or hr-HPV DNA)
Previous cervical ablation procedure or loop electrosurgical excision procedure LEEP
Past history of CIN
Immunocompromised Immunosuppressant
Pregnancy or Lactation
Warts/ any other acute vulvovaginal infection
Distorted shape of cervix due to old tears |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients reporting symptomatic relief
Change in symptom assessed through visual analog scale
|
assessed at 6wks and 3months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
adverse effect
time taken for resolution of symptoms
patient satisfaction
|
6wks & 3months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/05/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/06/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
women with complain of recurrent or persistent vaginal discharge with cervical ectropion on per speculum examination will be recruited in the study after meeting eligibility criteria. thermalablation will be performed using wisap thermoablator ,which is a hand held device. the tip of probe will be placed at ectropion area for 40 sec and ablation will be performed. women with infective discharge will be first treated and then thermalablation will be performed. After ablation women will be followed at 6wks and 3m for symptom improvement. |