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Vaginoscopy vs Traditional Hysteroscopy for Fibroids

N/A
Waitlist Available
Led By Carole KAMGA-NGANDE, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Polyp less than 2 cm
If more than 1 fibroid: total fibroid have to be less or equal 4 cm
Must not have
Cervical stenosis
Blood dyscrasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a new way to do a hysteroscopy (vaginoscopy) is less painful than the traditional method.

Who is the study for?
This trial is for women aged 18-52 who need a polypectomy or myomectomy due to abnormal bleeding or fertility issues. They must have small polyps or fibroids previously diagnosed by hysteroscopy. Women with large fibroids, cervical stenosis, blood disorders, or pregnancy cannot participate.
What is being tested?
The study compares pain levels between two procedures: vaginoscopy and traditional hysteroscopy during outpatient treatment of uterine conditions like fibroids. The hypothesis is that vaginoscopy causes less pain than the standard method.
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include discomfort, cramping, bleeding similar to menstrual periods, and possible infection risks associated with hysteroscopic procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My polyp is smaller than 2 cm.
Select...
My fibroids are 4 cm or smaller in total if I have more than one.
Select...
I have a small fibroid inside the wall of my uterus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a narrowed cervical canal.
Select...
I have a blood disorder.
Select...
I have a polyp or fibroid larger than 2 cm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hysteroscopy
Secondary study objectives
Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group
Hysteroscopy
Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VaginoscopyExperimental Treatment1 Intervention
morcellation hysteroscopy with only intravenous sedation
Group II: Standard hysteroscopyActive Control1 Intervention
morcellation hysteroscopy with intravenous sedation and paracervical bloc
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vaginoscopy
2019
N/A
~40

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,442 Total Patients Enrolled
Hologic, Inc.Industry Sponsor
47 Previous Clinical Trials
60,104 Total Patients Enrolled
Carole KAMGA-NGANDE, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)

Media Library

standard hysteroscopy Clinical Trial Eligibility Overview. Trial Name: NCT04373694 — N/A
Fibroid Research Study Groups: Standard hysteroscopy, Vaginoscopy
Fibroid Clinical Trial 2023: standard hysteroscopy Highlights & Side Effects. Trial Name: NCT04373694 — N/A
standard hysteroscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04373694 — N/A
~15 spots leftby Dec 2025
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