Comparison of Three Cannulas for Hysterosalpingography
1 other identifier
interventional
114
1 country
1
Brief Summary
The aim of this study is to compare the three commonly used hysterosalpingography (HSG) injection devices on the basis of patient pain perception, total fluoroscopic and procedural time, and side effects in a prospective, randomized study. An important and novel secondary outcome is the comparison of the quality of images obtained with these three devices. The investigators hypothesize that the balloon catheter and cervical vacuum cup will be less painful than the acorn tipped cannula and that there will be no difference in image quality between the three groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedApril 25, 2022
February 1, 2013
1 year
August 10, 2009
April 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain scores
15 minutes
Secondary Outcomes (4)
the total duration of the procedure
15 minutes
direct fluoroscopic time
15 minutes
rates of vasovagal reaction
15 minutes
diagnostic quality of images obtained
1 month
Study Arms (3)
Balloon Catheter
ACTIVE COMPARATORCervical Vacuum Cup
ACTIVE COMPARATORacorn-tipped cannula
ACTIVE COMPARATORInterventions
Use of acorn-tipped cannula for HSG to evaluate tubal patency
cup placed over cervix to create vacuum pressure.
balloon inserted via catheter into cervic for dilation.
Eligibility Criteria
You may qualify if:
- Women undergoing HSG at an academic medical center
You may not qualify if:
- Contrast media allergy
- Prior LEEP (Loop Electrosurgical Excision Procedure) or other cervical procedure
- Contraindication to NSAID use
- Known active pelvic infection
- Active vaginal bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Lane, MD
Carolinas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 11, 2009
Study Start
February 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
April 25, 2022
Record last verified: 2013-02