Trials / Unknown
UnknownNCT02283463
Novel Cervical Retraction Device
Patient Discomfort With a Novel Suction Based Cervical Retractor Compared to the Traditional Cervical Tenaculum
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Bioceptive · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intrauterine device (IUD) insertion | |
| PROCEDURE | Endometrial biopsy |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2018-02-01
- First posted
- 2014-11-05
- Last updated
- 2017-07-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02283463. Inclusion in this directory is not an endorsement.