Study to Assess the Safety and Efficacy of the IUB SEAD™ Device — AUB  

Abnormal Uterine Bleeding Clinical Trial

Official title: Pre-pivotal, Randomized Study to Assess the Safety and Efficacy of the IUB SEAD™ Device in Women Suffering From Abnormal Uterine Bleeding

Status Completed

Clinical Trial Summary

Pre-pivotal, randomized study to assess the safety and efficacy of the IUB SEAD™ device in women suffering from abnormal uterine bleeding.

Clinical Trial Description

Chronic abnormal uterine bleeding (AUB), involving menstrual bleeding of abnormal quantity, duration, or schedule, is experienced by 10-35% of women, and can markedly impact everyday activities, can lead to iron deficiency and in severe cases, can necessitate emergency medical care.

While pharmacologic treatment options exist, some women desire a treatment that requires less maintenance or is definitive. Endometrial ablation is a minimally invasive approach applied to manage AUB and can be performed using resectoscopic instruments or with a non-resectoscopic approach, in which the device is inserted into the uterine cavity and delivers energy to uniformly destroy the uterine lining. Non-resectoscopic endometrial ablation has become an accepted office-based procedure, but requires training in administration and response to complications of conscious sedation and of assisting personnel.

The IUB SEAD™ device is a novel Spherical Endometrial Ablation Device, developed to allow for a simple, office-based chemical endometrial ablation to treat AUB. The suggested procedure is expected to be simpler than the currently available ablation methods and to result in a clinically meaningful delay or abolishment of the need for hysterectomy ;

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Hemorrhage
• Uterine Hemorrhage

• NCT number: NCT04381416
• Study type: Interventional
• Source: Ocon Medical Ltd.
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Completion date: December 31, 2022