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To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carevix | Experimental | suction cervical stabilizer utilized for intrauterine procedures |
|
| Tenaculum | Active Comparator | standard of care cervical stabilization device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carevix | Device | Cervical stabilization device that uses vacuum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-perceived Pain | Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Participants fill out their survey once the procedure and clinical appointment is concluded. | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Provider-perceived Bleeding | Bleeding perceived by the provider during and after the procedure. | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) |
| Provider-perceived Ease of Use |
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Inclusion Criteria:
• Age 18 years or older
Exclusion Criteria:
• Vaginal bleeding of unknown origin
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| Name | Affiliation | Role |
|---|---|---|
| Alissa Conklin, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36914147 | Background | Yaron M, Legardeur H, Barcellini B, Akhoundova F, Mathevet P. Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device insertion: Results from a randomized, controlled study. Contraception. 2023 Jul;123:110004. doi: 10.1016/j.contraception.2023.110004. Epub 2023 Mar 11. |
| Label | URL |
|---|---|
| journal article | View source |
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Patients were ineligible if they did not meet these criteria, as well as if they presented with vaginal bleeding of unknown origin, cervix less than 26 mm in diameter, Nabothian cyst on anterior lip of cervix, cervical myomas, cervical abnormalities/shape, or if they were pregnant. Patients were also designated ineligible if they did not receive any cervical stabilization. Patients were recruited in two waves corresponding with each arm.
Patients were recruited from a women's health clinic in Indianapolis. Enrolled participants were at least 18 years old, English-speaking, and scheduled to undergo an intrauterine procedure. A total of 73 patients were enrolled with 60 eligible participants who received cervical stabilization during their procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Carevix | Suction cervical stabilizer utilized for intrauterine procedures Carevix: Cervical stabilization device that uses vacuum |
| FG001 | Tenaculum | Standard of care cervical stabilization device Tenaculum: standard of care cervical stabilization device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carevix | Suction cervical stabilizer utilized for intrauterine procedures Carevix: Cervical stabilization device that uses vacuum |
| BG001 | Tenaculum | Standard of care cervical stabilization device Tenaculum: standard of care cervical stabilization device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient-perceived Pain | Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Participants fill out their survey once the procedure and clinical appointment is concluded. | Participants who underwent an intrauterine procedure with either the Carevix device or the Tenaculum. | Posted | Median | Inter-Quartile Range | score on a scale | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) |
|
Adverse events were assessed by providers during follow-up visits or patient reported, up to 2-months post-procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carevix | Suction cervical stabilizer utilized for intrauterine procedures Carevix: Cervical stabilization device that uses vacuum |
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Not all clinic providers wanted to participate in the trial which hindered recruitment. Similarly, not all providers consistently utilized ANY cervical stabilization which rendered otherwise eligible participants unable to continue in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alissa M Conklin | Indiana University Health | 317.944.8231 | alconkli@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2024 | Apr 3, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Carevix arm ICF | Jan 29, 2024 | Apr 3, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Tenaculum arm ICF | Jan 29, 2024 | Apr 3, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| Tenaculum |
| Device |
standard of care cervical stabilization device |
|
Providers will report their perceived ease of use with the Carevix device indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. |
| Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) |
| Provider-perceived Satisfaction | Providers will report their perceived satisfaction indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. In the Tenaculum arm, providers reported if they preferred the cervical tenaculum to the Carevix device. Providers complete their portion of the survey after the appointment is concluded. | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Highest level of complete education | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Nulliparous/Multiparous | Count of Participants | Participants |
|
| OG001 |
| Tenaculum |
Standard of care cervical stabilization device Tenaculum: standard of care cervical stabilization device |
|
|
|
| Secondary | Provider-perceived Bleeding | Bleeding perceived by the provider during and after the procedure. | Providers who completed the intrauterine procedure with their respective participants. | Posted | Count of Participants | Participants | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) |
|
|
|
|
| Secondary | Provider-perceived Ease of Use | Providers will report their perceived ease of use with the Carevix device indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. | Providers were only asked about the "Ease of use" for the Carevix device. | Posted | Count of Participants | Participants | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) |
|
|
|
| Secondary | Provider-perceived Satisfaction | Providers will report their perceived satisfaction indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. In the Tenaculum arm, providers reported if they preferred the cervical tenaculum to the Carevix device. Providers complete their portion of the survey after the appointment is concluded. | Providers who completed the intrauterine procedure with their respective participants. | Posted | Count of Participants | Participants | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Tenaculum | Standard of care cervical stabilization device Tenaculum: standard of care cervical stabilization device | 0 | 37 | 0 | 37 | 0 | 37 |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Married |
|
| Divorced |
|
| Widowed |
|
| Other |
|
| Prefer not to say |
|
| Some college |
|
| Associate, Technical, or 2 year degree |
|
| Bachelor's or 4 year degree |
|
| Master's degree |
|
| Doctorate |
|
| License or Professional Certification |
|
| Other |
|
| Prefer not to say |
|
| Part-time (less than 40 hours a week) |
|
| Full-time (40+ hours a week) |
|
| Self-employed, Freelance, or Contractor |
|
| Retired |
|
| Other |
|
| Prefer not to say |
|
| Student and Part-time |
|
| Student and Full-time |
|
| Missing |
|
| Strongly Disagree |
|
| I don't know/Not sure |
|
| I don't know not sure |
|
| Disagree |
|
| Strongly Disagree |
|