Cervical CancerNCT06359431
A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening
A study testing Novel Smart Speculum and Standard speculum in people with Cervical Cancer, run by GICMED at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Novel Smart Speculum and Standard speculum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Jun 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women aged between 21 to 49 years who will consent to participate in the study
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Cervical Cancer
- Being tested
- Novel Smart Speculum, Standard speculum
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Smart SpeculumDevice
The examiner will lubricate the intended speculum with a water-based lubricant then insert through the vagina. Immediately after the first speculum is inserted, and before the examiner attempts to expand the blades to visualize the cervix, the participant's comfort will be assessed using a modified version of the 0-10 Universal Pain Assessment Tool, which shows a series of faces ranging from happy face at 0, or "no pain", to a crying face at 10, which represents "worst pain possible". Her response will be recorded immediately.
Then the examiner will open the speculum adequately to visualise the cervix. At this point, the visual analogue scale will be given to the participant and told to indicate again the level of pain following manipulation of the speculum, using a scale of 0 (no pain) to 10 (the worst pain imaginable). Her response will be recorded immediately.
Standard speculumDevice
he examiner will lubricate the intended speculum with a water-based lubricant then insert through the vagina. Immediately after the first speculum is inserted, and before the examiner attempts to expand the blades to visualize the cervix, the participant's comfort will be assessed using a modified version of the 0-10 Universal Pain Assessment Tool, which shows a series of faces ranging from happy face at 0, or "no pain", to a crying face at 10, which represents "worst pain possible". Her response will be recorded immediately.
Then the examiner will open the speculum adequately to visualise the cervix. At this point, the visual analogue scale will be given to the participant and told to indicate again the level of pain following manipulation of the speculum, using a scale of 0 (no pain) to 10 (the worst pain imaginable). Her response will be recorded immediately.
| Study group | Role | What they receive |
|---|---|---|
| Standard Speculum/Novel Speculum | Active comparator | In this arm, the standard speculum will be administered before the novel speculum Receives: Device: Novel Smart Speculum; Device: Standard speculum |
| Novel Speculum/Standard Speculum | Active comparator | In this arm, the novel speculum will be administered before the standard speculum Receives: Device: Novel Smart Speculum; Device: Standard speculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization
The proportion of clinicians with easy visualisation of the cervix with the 2 specula, level of patient comfort for the novel smart speculum compared to the standard of care speculum,
Measured: Up to 4 months
Reliability in cervical cancer screening using a questionnaire
reliability of the speculum in carrying out cervical cancer screening using telemedicine
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Jun 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- GICMED
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fai Karl Gwei Njuwa, GICMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359431
- Sponsor's protocol ID
- 1604/CE/CNERSH/SP
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT06359431
- Acronym / sponsor ID
- 1604/CE/CNERSH/SP
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- GICMEDUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Speculum/Novel Speculum | Active comparator | Device: Novel Smart Speculum, Device: Standard speculumIn this arm, the standard speculum will be administered before the novel speculum |
| Novel Speculum/Standard Speculum | Active comparator | Device: Novel Smart Speculum, Device: Standard speculumIn this arm, the novel speculum will be administered before the standard speculum |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women aged between 21 to 49 years who will consent to participate in the study
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Smart SpeculumThe examiner will lubricate the intended speculum with a water-based lubricant then insert through the vagina. Immediately after the first speculum is inserted, and before the examiner attempts to expand the blades to visualize the cervix, the participant's comfort will be assessed using a modified version of the 0-10 Universal Pain Assessment Tool, which shows a series of faces ranging from happy face at 0, or "no pain", to a crying face at 10, which represents "worst pain possible". Her response will be recorded immediately. Then the examiner will open the speculum adequately to visualise the cervix. At this point, the visual analogue scale will be given to the participant and told to indicate again the level of pain following manipulation of the speculum, using a scale of 0 (no pain) to 10 (the worst pain imaginable). Her response will be recorded immediately. | Device | Novel Speculum/Standard Speculum, Standard Speculum/Novel Speculum |
| Standard speculumhe examiner will lubricate the intended speculum with a water-based lubricant then insert through the vagina. Immediately after the first speculum is inserted, and before the examiner attempts to expand the blades to visualize the cervix, the participant's comfort will be assessed using a modified version of the 0-10 Universal Pain Assessment Tool, which shows a series of faces ranging from happy face at 0, or "no pain", to a crying face at 10, which represents "worst pain possible". Her response will be recorded immediately. Then the examiner will open the speculum adequately to visualise the cervix. At this point, the visual analogue scale will be given to the participant and told to indicate again the level of pain following manipulation of the speculum, using a scale of 0 (no pain) to 10 (the worst pain imaginable). Her response will be recorded immediately. | Device | Novel Speculum/Standard Speculum, Standard Speculum/Novel Speculum |
Primary outcome
Visualization
Time frame: Up to 4 months
The proportion of clinicians with easy visualisation of the cervix with the 2 specula, level of patient comfort for the novel smart speculum compared to the standard of care speculum,
Reliability in cervical cancer screening using a questionnaire
Time frame: Up to 4 months
reliability of the speculum in carrying out cervical cancer screening using telemedicine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Smart Speculum and Standard speculum in people with Cervical Cancer, run by GICMED at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization (time frame: Up to 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.