NCT06359431

A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening

Not yet recruiting NA Last updated 11 April 2024

What this trial tests

NA trial testing Novel Smart Speculum in Cervical Cancer in 81 participants. Not yet recruiting.

Timeline

1 April 2024

Primary endpoint
30 June 2024

30 July 2024

Quick facts

Lead sponsor	GICMED
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	screening
Enrollment	81
Start date	1 April 2024
Primary completion	30 June 2024
Estimated completion	30 July 2024

Drugs / interventions tested

• Novel Smart Speculum
• Standard speculum

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

GICMED

Who can join

Adults 21 to 49, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.