NCT04381416

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ocon Medical Ltd. · Industry
• Sex: Female
• Age: 35 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Abnormal Uterine Bleeding

Interventions

Type	Name	Description
DEVICE	SEAD treatment	up to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic

Timeline

• Start date: 2019-09-01
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2020-05-08
• Last updated: 2023-11-08

Locations

1 site across 1 country: Bulgaria