NCT05606146

IUB SEAD RED (Revolutionary Endometrial Ablation Device Study)

Phase IIc (Protocol 55P127): Addition of up to 10 Women to Explore Silver Systemic Absorption as a Continuation Study to: Phase IIb (Protocol 55P140)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ocon Medical Ltd. · Industry
• Sex: Female
• Age: 40 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

One of the AUB symptoms, heavy menstrual bleeding (HMB), can lead to iron deficiency and iron deficiency anemia and in acute and severe cases, can necessitate emergency medical care. This study's focus is on the symptom of HMB which has a number of benign causes. The investigative device, the IUB SEAD™, is a novel spherical endometrial ablation device developed to allow for simple, office-based chemical EA to treat benign causes of the symptom of HMB. The suggested procedure is expected to be simpler than the currently available EA methods and yet should still reduce the need for a hysterectomy.

Detailed description

Chronic abnormal uterine bleeding (AUB), involving menstrual bleeding of abnormal quantity, duration, frequency, or regularity is experienced by 10-50% of women of reproductive age, adversely impacts quality of life, and can have substantial adverse economic impacts on patients, and healthcare systems. One of the AUB symptoms, heavy menstrual bleeding (HMB), can lead to iron deficiency and iron deficiency anemia and in acute and severe cases, can necessitate emergency medical care. This study's focus is on the symptom of HMB which has a number of benign causes. While pharmacologic treatment options exist, they are not always effective, and they are frequently associated with both side effects and ongoing cost of care. Consequently, some women desire more definitive options. Endometrial ablation (EA) is a minimally invasive approach designed to manage a number of the causes of HMB and can be performed under direct intrauterine vision with resectoscopic instruments or with a non-resectoscopic approach (non-resectoscopic endometrial ablation or NREA). For NREA, one of a number of specially designed device is inserted into the endometrial cavity to deliver thermal, cryogenic or radiofrequency electrical energy in an attempt to destroy the uterine lining or endometrium. In some jurisdictions, NREA has become an accepted office-based procedure, but is still usually performed in an institutional setting, is associated with risks associated with the procedure, anesthesia, and subsequent infertility, and has a failure rate that averages about 26%. These devices are typically expensive and require training for the surgeon and the ancillary support staff. The investigative device, the IUB SEAD™, is a novel spherical endometrial ablation device developed to allow for simple, office-based chemical EA to treat benign causes of the symptom of HMB. The suggested procedure is expected to be simpler than the currently available EA methods and yet should still reduce the need for a hysterectomy. This study will evaluate an additional exploratory endpoint in order to evaluate if there are detectable levels of silver in blood following SEAD treatment. SEAD treatment is performed locally by intrauterine administration for a duration of 30 minutes, during which the silver nitrate beads gradually dissolve. Upon dissolution the silver ions act on the mucus layer of the endometrium by binding to proteins and causing their denaturation, resulting in the formation of an eschar. The effect is local, and the bound silver is no longer active therefore it is unlikely that 100% of the silver dose will be available for absorption.

Conditions

• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DEVICE	IUB SEAD	The investigative device, the IUB SEAD™, is a novel spherical endometrial ablation device developed to allow for simple, office-based chemical EA to treat benign causes of the symptom of HMB

Timeline

• Start date: 2023-02-23
• Primary completion: 2024-03-01
• Completion: 2024-07-01
• First posted: 2022-11-04
• Last updated: 2023-11-09

Locations

1 site across 1 country: Israel