Gel instillation sonohysterography (GIS) using Endosgel versus ExEmgel, comparison of pain and image quality

Phase 4

Completed

• Conditions: intra-uterine abnormalities; polyp; submucous fibroid; 10038612

• Registration Number: NL-OMON38342
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-02-10
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

- woman with abnormal uterine bleeding or infertility and suspected for having an intrauterine abnormality
- Age 20-80 yr

Exclusion Criteria

- Pregnancy or premenopausal women in the luteal phase without use of contraception
- Pelvic Inflammatory Disease (PID)
- Risk of malignancy
- Contraindication for the use of NSAIDS
- Known allergy for chloorhexidine
- Inability to understand Dutch or English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is AUC of continuous registered pain score (continuous VAS)<br /><br>during gel installation and following sonography.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other outcome parameters are pain score (AUC using continuous pain<br /><br>registration) of the entire procedure and of specific parts of the procedure,<br /><br>subjective reported VAS score and image quality. Various prognostic factors<br /><br>will be registered.</p><br>