A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening - Trial NCT06359431

Timeline & Enrollment

Primary Outcome

Visualization,Reliability in cervical cancer screening using a questionnaire

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.

ICD-10 Classifications