Clinical trial NCT06359431: A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening
Official title: A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: GICMED
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 81
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Objective: The main objective of this study is to verify the level of comfort for patients and the degree of cervical visibility for health providers using a novel smart speculum compared to the standard speculum. In addition, establish the feasibility of using this novel smart speculum device with telemedicine for cervical cancer screening in a low-resource setting using VIA compared to the standard of care.

Study sites: The study will be carried out in six health facilities in the centre region of Cameroon.

Study Period: The study is expected to take 11 months; 4 months for protocol development and approval, 4 months for the training and implementation phase with data collection, 3 months for data analysis, reporting writing and dissemination.

Study design: The study will be a multicentre, randomised control single blind trial. Patient participation will be a single study visit. Eligible subjects, consenting to participate will act as their own controls, and will receive speculum examination and cervical cancer screening with both the novel speculum and a traditional speculum. The order of usage of the specula will be randomised, and the women will be blinded on knowing which speculum is being used at a particular time. Level of patient comfort will be evaluated using a visual analogue scale, percentage visualisation of the cervix will be determined following insertion of each of the specula, and results of cervical cancer screening following VIA screening method will be compared between the standard of care procedure to that using the novel smart speculum associated to telemedicine.

Patient population: All women between the ages of 21 years and 49 years who come in for consultation.

Enrolment size: 81 women will be enrolled in the study. Study procedure: A speculum examination will be done on the day of consultation. Level of patient comfort determined using a visual analogue scale and proportion of the cervix visualised would be recorded into questionnaires. Cervical cancer screening through VIA will be performed with results confirmed on site by the clinician using the standard speculum, while two other clinicians for each case will do a remote diagnosis after reviewing images captured through the novel speculum device and forwarded to them through telemedicine. The remote clinicians will be blinded on the diagnosis proposed by the clinician on site.

Primary endpoints: The proportion of clinicians with easy visualisation of the cervix with the 2 specula, level of patient comfort with the novel smart speculum compared to the Standard of care speculum (traditional speculum), reliability of the speculum in carrying out cervical cancer screening using telemedicine.

Ethical considerations: The protocol will be submitted for the approval of the National Human Health Research Committee. Written informed consent will be sought for all participants before enrolment into the study.


Eligibility criteria: Inclusion Criteria:

* All women aged between 21 to 49 years who will consent to participate in the study

Exclusion Criteria:

* Women who have previously been diagnosed with and/or treated for cervical pre- cancer and cancer with surgical removal of part of the cervix will be excluded.
* Women in the menstrual periods, vulvar atrophy, interstitial cystitis, chronic pelvic pain, vestibulodynia, vaginitis or menopausal.
* Women who have never had any sexual intercourse before (virgins).

Primary outcomes:
measure: Visualization
timeFrame: Up to 4 months
measure: Reliability in cervical cancer screening using a questionnaire
timeFrame: Up to 4 months
Secondary outcomes:
Other outcomes:
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Study officials:
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