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| Name | Class |
|---|---|
| MDI Worldwide LLC | UNKNOWN |
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The purpose of this study is to estimate if a novel sheathed speculum provides improved visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate if the sheathed speculum causes less discomfort during the examination.
This is a randomized trial where physician investigators will perform clinically indicated vaginal speculum examinations using either a sheathed or a standard plastic speculum, to determine which speculum provides the best visualization of the cervix. As a secondary outcome, study participants will record their pain level on a 10-cm visual analogue scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sheathed speculum | Active Comparator | Investigators will perform a vaginal speculum examination with either a sheathed or a standard ("non sheathed" speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception. |
|
| Standard speculum examination | Active Comparator | Investigators will perform a vaginal speculum examination with either a standard or a sheathed speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sheathed speculum examination | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of cervix visualized. | To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum. | During vaginal speculum examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pain during speculum examination. | To compare the subjects' comfort level between the sheathed and standard speculums when undergoing a vaginal speculum examination, using a patient-reported 10-cm visual analog scale (VAS). | During speculum examination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Hill, M.D. | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loch Haven Ob/Gyn Group | Orlando | Florida | 32804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24565103 | Derived | Hill DA, Cacciatore ML, Lamvu G. Sheathed versus standard speculum for visualization of the cervix. Int J Gynaecol Obstet. 2014 May;125(2):116-20. doi: 10.1016/j.ijgo.2013.10.025. Epub 2014 Feb 1. |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| D017280 | Condoms |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D003275 | Contraceptive Devices, Male |
| D003273 | Contraceptive Devices |
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| Standard speculum examination | Procedure |
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