Your session is about to expire
← Back to Search
Cervical Retraction Device for Post-Procedural Pain
N/A
Waitlist Available
Led By David Turok, MD, MPH
Research Sponsored by Bioceptive
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects presenting for IUD insertion or endometrial biopsy
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Study Summary
This trial will test a suction-based method of engaging the cervix, which may diminish pain and discomfort.
Who is the study for?
This trial is for women who can consent in English or Spanish and are undergoing an IUD insertion or endometrial biopsy. It's not open to pregnant women, those with cervical abnormalities, post-menopausal women, or anyone who has used narcotics or benzodiazepines before the procedure.Check my eligibility
What is being tested?
The study tests a new device by Bioceptive that attaches gently to the cervix during gynecologic procedures like IUD insertions and biopsies. The aim is to see if this suction-based method reduces pain compared to traditional methods.See study design
What are the potential side effects?
Since it's a minimal risk device designed to be gentle and non-traumatic, side effects may be less than current methods but could include discomfort at the attachment site or minor bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am going for an IUD insertion or endometrial biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Intensity Measure 100 point visual analogue scale
Secondary outcome measures
Procedural Satisfaction Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bioceptive Cervical Retraction DeviceExperimental Treatment2 Interventions
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.
Group II: Standard Cervical TenaculumActive Control2 Interventions
Single tooth tenaculum, pierces the tissue of the cervix to allow provider to stabilize and place traction on the cervical cal/uterus
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endometrial biopsy
2013
Completed Phase 3
~960
Find a Location
Who is running the clinical trial?
BioceptiveLead Sponsor
David Turok, MD, MPHPrincipal InvestigatorUniversity of Utah, Dept. of Obstetrics and Gynecology
4 Previous Clinical Trials
3,073 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have gone through menopause.I can give my consent in English or Spanish.I am going for an IUD insertion or endometrial biopsy.I have an abnormal growth or area in my cervix.I have used narcotics or Benzodiazepines before the procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Cervical Tenaculum
- Group 2: Bioceptive Cervical Retraction Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria need to be fulfilled for individuals to participate in this research?
"Acceptance into this clinical trial necessitates that potential participants suffer from pain due to a particular procedure and are between 18-45 years old. Presently, the team is looking for 24 volunteers."
Answered by AI
Does the enrollment criteria for this medical trial encompass individuals younger than sixty years of age?
"The age range for eligibility is 18-45, as specified in the criteria for participant selection."
Answered by AI
Are there any eligibility requirements to join this research project?
"The clinicaltrials.gov page confirms that this trial is no longer recruiting patients, with the original listing being posted on September 1st 2014 and last updated July 18th 2017. However, there are currently other trials actively enrolling participants at the moment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger