| CTRI Number |
CTRI/2024/12/077719 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Clinical validation study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the functioning of menstrual fluid collection Device M-StripTM
|
|
Scientific Title of Study
|
An Open Label Clinical Investigation to Assess and Measure the Functionality of Menstrual Fluid
Collection Device- M- StripTM
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/MD/006 Version 1.1 & Dated 04NOV2024 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Somesh Chandra |
| Designation |
Principal Investigator |
| Affiliation |
Sterling Hospital |
| Address |
6th Floor, Clinical Research Dept, Sterling Hospital, Gurukul, Memnagar, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380052
India |
| Phone |
09426014627 |
| Fax |
|
| Email |
someshchandra@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Somesh Chandra |
| Designation |
Principal Investigator |
| Affiliation |
Sterling Hospital |
| Address |
6th floor, Clinical Research Dept, Sterling Hospital, Gurukul Memnagar, Ahmedabad
Ahmadabad
GUJARAT
380052
India |
| Phone |
09426014627 |
| Fax |
|
| Email |
someshchandra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO representative |
| Affiliation |
TrialGuna Private Limited |
| Address |
#467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
09972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Iota Diagnostic Private Limited, #10 CrAdLE-EDII Institute, Airport Road, Indira Bridge, Gandhinagar,
Gujarat – 382428 |
|
|
Primary Sponsor
|
| Name |
IOTA Diagnostic Private Limited |
| Address |
Iota Diagnostic Private Limited, #10 CrAdLE-EDII Institute, Airport Road, Indira Bridge, Gandhinagar,
Gujarat – 382428 |
| Type of Sponsor |
Other [Research and Product Development] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Somesh Chandra |
Sterling Hospital |
6th floor, Clinical Research Dept, Sterling Hospital, Gurukul Memnagar Ahmadabad- 380052
Ahmadabad
GUJARAT |
9426014627
someshchandra@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sterling Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Female Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy women volunteers are chosen aged 30 and 55 years.
2.Subjects who are willing to participate in the study and sign the
informed consent document and comply with the trial procedure.
3.Subjects who are compliant with the study. |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Clinical evidence of any serious systemic disease or acute illness, in the
clinical opinion of the Investigator.
3.Subjects who are surgically sterile or have attained menopause (if they
had their last menstruation more than 2 years back.
4.Subjects who were previously included or had participated in any other
clinical study within 30 days prior to the date of consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Proportion of adequate samples for evaluation out of total samples collected.
2.Concordance between HPV positive samples in Menstrual blood collected using M StripTM versus conventional method |
Day 1, Day 2 & Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Laboratory analysis and confirmation of the menstrual blood samples collected on the first three days of menstruation.
2. The prevalence of the different high risk HPV subtypes and the associated
cyto-morphological status of the cervix. |
Day 1, Day 2 & Day 3 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "175"
Final Enrollment numbers achieved (India)="175" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
28/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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)
|
The M-Strip Menstrual fluid collection device was evaluated
as a safe, non-invasive method that consistently collected adequate menstrual
blood for hr-HPV testing, with 100 Percentage sample adequacy among 145
evaluable women participants and no device-related serious adverse events. In
this open-label clinical investigation, 175 healthy women aged 30 to 55 years
were enrolled, and 145 participants completed the study. The device
demonstrated high concordance with conventional cervical smear or liquid based
cytology (LBC) testing, including 93.10 percentage overall agreement, 95.45
percentage negative percent agreement, 69.23 percentage positive percent
agreement, and moderate but statistically significant agreement by Cohens kappa
(0.604; p less than 0.001). The study also detected multiple clinically
relevant high-risk HPV genotypes, including HPV 16, 33, 35, 39, 51, 56, 58, 59,
and 68. These findings indicate that the M-Strip™ is a safe, well-tolerated,
and effective alternative to speculum-based sample collection, with potential
to expand access to HPV-based cervical cancer screening and broader hr-HPV
detection. |