Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study

Summary

Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss. Chronic AUB refers to irregularities in menstrual bleeding for most of the previous 6 months. AUB can be frequent or infrequent, prolonged, irregular, or heavy. Heavy menstrual bleeding (HMB) is defined as "excessive menstrual blood loss which interferes with a woman's physical, social, emotional and/or material quality of life". Causes of AUB are classified as polyps, adenomyosis, leiomyomas (AUB-L), malignancy and premalignant conditions, coagulopathy, ovulatory disorders (AUB-O), endometrial disorders (AUB-E), iatrogenic, and ''not classified'' . AUB affects approximately one in four women between 30 and 50 years of age, with serious implications on woman's quality of life (QoL). Endometrial ablation (EA) is a uterus-preserving procedure that aims to destroy or remove the endometrial tissue in selected women who have no desire for future fertility. EA has become an alternative to hysterectomy in the treatment of AUB because it is less invasive and has a shorter recovery period. At present, many different techniques are available to remove the endometrial tissue. Resectoscopic endometrial ablation (REA) consists of targeted endometrial destruction under direct hysteroscopic visualization. REA techniques include endometrial laser ablation, transcervical resection of the endometrium, and rollerball endometrial ablation. Non-resectoscopic endometrial ablation (NREA) uses a variety of energy sources to non-selectively destroy the endometrial lining and include thermal balloon endometrial ablation, microwave endometrial ablation, hydrothermal ablation, bipolar radiofrequency endometrial ablation, endometrial cryotherapy, and more recently vapor endometrial ablation. NREA technologies require short surgical time and can also be performed in the outpatient setting. Vapor EA is one of the newest approaches in the field. In this context, the Aqua Therapeutics Thermal Therapy Vapor Ablation system (ATTTVAS; AQUA Therapeutics Inc.) is a novel system designed to ablate uterine tissue using vapor thermal therapy technology.

The ATTTVAS is indicated to ablate the endometrial lining of the uterus in premenopausal women with abnormal uterine bleeding (AUB) due to benign causes for whom childbearing is complete. In this Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation we aim to evaluate the Safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in premenopausal women with AUB.

Conditions

• Uterine Hemorrhage

Interventions

DEVICE

Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)

The Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) is indicated to ablate the endometrial lining of the uterus in premenopausal women with abnormal uterine bleeding (AUB) due to benign causes for whom childbearing is complete. The ATTTVAS is intended to be used by qualified healthcare professionals specifically trained in the field of endometrial ablation. The ATTTVAS is intended for outpatient use although it can easily be utilized in both a surgery centre and the operating room as well.

Sponsors & Collaborators

• Aqua Therapeutics, Inc.

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-28

Primary Completion

2025-12-01

Completion

2025-12-01

Countries

• Italy
• Netherlands

Study Locations