Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
The Use of a Novel Vaginal Speculum for Cervical Cancer Screening in Sunrise Community Health Patients
Sponsor:
Rocky Vista University LLC
Organization:
Rocky Vista University LLC
Study Overview
Official Title:
Evaluating the Efficacy and Use of the Bouquet Speculum for Cervical Cancer Screening in a Diverse Population of Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The specific aim of this research is to determine if the Bouquet Speculum TM compared to the existing 2-bladed vaginal speculum provides better visualization of the cervix is easier for the provider to use and is more comfortable for the patient
Additionally the clinicians experience with vaginal speculum exams and the patients last vaginal speculum exam parity and self-reported weight classification will be surveyed to see what effect if any it has on visualization of the cervix ease-of use and comfort level for the patient
The objective of this project is to investigate the use of a novel FDA-cleared 5-petaled vaginal speculum in cervical cancer screening Pap test andor HPV probe on 200 patients from Sunrise Community Health Clinics in the Denver-Metro area
Additionally the clinicians experience with vaginal speculum exams and the patients last vaginal speculum exam parity and self-reported weight classification will be surveyed to see what effect if any it has on visualization of the cervix ease-of use and comfort level for the patient
The objective of this project is to investigate the use of a novel FDA-cleared 5-petaled vaginal speculum in cervical cancer screening Pap test andor HPV probe on 200 patients from Sunrise Community Health Clinics in the Denver-Metro area
Detailed Description:
The Bouquet Speculum TM will be used by a variety of clinicians at Sunrise Clinics including physicians PAs and NPs for routine cervical cancer screening including Pap tests andor HPV probes 200 women will be selected from the Sunrise Clinics in the Denver-Metro area Women who do not have a cervix or have never had a vaginal speculum exam will be excluded The inclusion criteria is women ages 18-65
The clinician will be provided with a one-page Instructions for Use document and a 2-minute instructional video on how to use the Bouquet Speculum TM The clinician will then be assigned a letter and complete three questions on a survey for each patient regarding 1 visualization of the cervix 2 ease-of-use 3 experience with speculum exams The patient will be consented and de-identified and assigned a number to their survey of four questions 1 comfort level 2 last vaginal speculum exam 3 self-reported description of weight underweight normal overweight obese 4 parity number of births
The length of the study is anticipated to be three months The surveys will be collected and tabulated and then evaluated by Dr Mark Payton who has experience with the Pakistan study
The Bouquet Speculum has been FDA-cleared and is a Class II medical device and poses a non-significant risk for use in humans
Proprietary Name Bouquet Vaginal Speculum Classification Name RETRACTOR VAGINAL Product Code HDL Device Class2 Regulation Number 8844520 Medical Specialty ObstetricsGynecology Registered Establishment Name Viospex Registered Establishment Number3012447313 OwnerOperator Viospex OwnerOperator Number10051911 Establishment Operations Manufacture
The clinician will be provided with a one-page Instructions for Use document and a 2-minute instructional video on how to use the Bouquet Speculum TM The clinician will then be assigned a letter and complete three questions on a survey for each patient regarding 1 visualization of the cervix 2 ease-of-use 3 experience with speculum exams The patient will be consented and de-identified and assigned a number to their survey of four questions 1 comfort level 2 last vaginal speculum exam 3 self-reported description of weight underweight normal overweight obese 4 parity number of births
The length of the study is anticipated to be three months The surveys will be collected and tabulated and then evaluated by Dr Mark Payton who has experience with the Pakistan study
The Bouquet Speculum has been FDA-cleared and is a Class II medical device and poses a non-significant risk for use in humans
Proprietary Name Bouquet Vaginal Speculum Classification Name RETRACTOR VAGINAL Product Code HDL Device Class2 Regulation Number 8844520 Medical Specialty ObstetricsGynecology Registered Establishment Name Viospex Registered Establishment Number3012447313 OwnerOperator Viospex OwnerOperator Number10051911 Establishment Operations Manufacture
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None