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This study will test a suction-based method of engaging the cervix. Bioceptive has developed a device that more gently and atraumatically attaches to the cervix with no bleeding. This novel attachment mechanism may diminish pain and discomfort. Pre-clinical testing has been performed on the device including testing on synthetic uterine models, human cadavers, and human uteri immediately post-hysterectomy (Utah IRB # 00059096). Results from these efforts have shown effective attachment to the cervix and the ability for the device to maintain suction throughout a procedure atraumatically. This study proposes to introduce this minimal risk device in a clinical setting to determine the response of women undergoing gynecologic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Cervical Tenaculum | Active Comparator | Single tooth tenaculum, pierces the tissue of the cervix to allow provider to stabilize and place traction on the cervical cal/uterus |
|
| Bioceptive Cervical Retraction Device | Experimental | Suction based method for stabilizing the cervix and uterus. Achieves suction 360 degrees around cervical os creating a portal through which instruments can be passed into the cervical canal and uterus. Provider can still place traction on uterus with this device just as with tenaculum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrauterine device (IUD) insertion | Device |
| ||
| Endometrial biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Measure 100 point visual analogue scale | Pain recorded by patient during the procedure and one day following via 100 point visual analogue scale. (0 = none, 100 = worst imaginable) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Satisfaction Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied) | Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied) | < 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Turok, MD, MPH | University of Utah, Dept. of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah, School of Medicine | Salt Lake City | Utah | 84106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30396906 | Derived | Turok DK, Simmons RG, Cappiello B, Gawron LM, Saviers-Steiger J, Sanders JN. Use of a novel suction cervical retractor for intrauterine device insertion: a pilot feasibility trial. BMJ Sex Reprod Health. 2018 Nov 5:bmjsrh-2017-200031. doi: 10.1136/bmjsrh-2017-200031. Online ahead of print. |
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| ID | Term |
|---|---|
| D007434 | Intrauterine Devices |
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
| D015202 | Protein Engineering |
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| Procedure |
|
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D009154 | Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |