Clinical trial · Interventional
The Use of a Novel Vaginal Speculum for Endometrial Biopsies
NCT07217353CI-TRIAL-00115200enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this clinical trial is to determine if a newly-designed and FDA-cleared vaginal speculum (the Bouquet Speculum) will provide better visualization of the cervical os, be easier and more efficient to use, provide more consistent outcomes and decrease the discomfort associated with endometrial biopsy procedures.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bouquet Speculum | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endometrial biopsies with a new vaginal speculum
- description
- The use of a novel, FDA-cleared vaginal speculum for endometrial biopsies
- interventionNames
- Device: Bouquet Speculum
Primary outcomes (1)
- measure
- Provider visualization of the cervix, ease of use, and accuracy of a new vaginal speculum being used for endometrial biopsies
- timeFrame
- Through study completion, an average of 1 year
- description
- A simple survey is filled out by the provider regarding whether the visualization of the cervix was better, the same, or worse with the new vaginal speculum. Similarly, the provider will be asked on the survey about the ease of use (easier, same more difficult). The last criteria will be de-identified data from the cohort to see if an adequate sample was obtained of the endometrium.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Biological women with a uterus, age 18-90 * Previous endometrial biopsy procedure performed at the Minnesota Oncology Clinic Exclusion Criteria: * Pregnant women, active pelvic infection, or uncontrolled bleeding dyscrasias as determined by the provider at Minnesota Oncology Clinics * Biological women without a uterus who are less than 18 years old or greater than 90 years old, or who have not had a previous endometrial biopsy at the Minnesota Oncology Clinic.
References
Publications (5)
- RESULTLuzarraga Aznar A, Canton R, Loren G, Carvajal J, de la Calle I, Masferrer-Ferragutcasas C, Serra F, Bebia V, Bonaldo G, Angeles MA, Cabrera S, Palomar N, Vilarmau C, Marti M, Rigau M, Colas E, Gil-Moreno A. Current challenges and emerging tools in endometrial cancer diagnosis. Int J Gynecol Cancer. 2025 Apr;35(4):100056. doi: 10.1016/j.ijgc.2024.100056. Epub 2024 Dec 18. PMID 40011116
- RESULTAmant F, Moerman P, Neven P, Timmerman D, Van Limbergen E, Vergote I. Endometrial cancer. Lancet. 2005 Aug 6-12;366(9484):491-505. doi: 10.1016/S0140-6736(05)67063-8. PMID 16084259
- RESULTKhan S, Waters-Kellar L, Barsh E, Shannon A, Clark S, Ryznar RJ, Trawick A, Payton M, Bouquet J. A Survey of Physicians and Patients in Pakistan Assessing the Improvement of Visualization of the Cervix, Ease of Use, and Patient Comfort Using a Newly Designed Vaginal Speculum: A Pilot Study. Med Devices (Auckl). 2025 Jun 11;18:309-317. doi: 10.2147/MDER.S509134. eCollection 2025. PMID 40599808
- RESULTBouquet JM, Morris E, Zapata I. A novel and cost-effective model to screen and treat cervical cancer and precancers at the point of care. Front Public Health. 2025 Apr 16;13:1527172. doi: 10.3389/fpubh.2025.1527172. eCollection 2025. PMID 40308928
- RESULTBouquet JM, Naji R, Armas CA, Roldan V, Selkhi S, Bentley CZ, Zapata I, Fisher J. An Innovative Design for the Vaginal Speculum. Med Devices (Auckl). 2023 Sep 25;16:211-218. doi: 10.2147/MDER.S415558. eCollection 2023. PMID 37790696