Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Leiomyoma

Myofibroma

Menorrhagia

Myoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)

Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)

GFA is radiofrequency ablation of fibroids. This is a laparoscopic procedure whereby a radiofrequency probe is inserted into the fibroid under laparoscopic and ultrasound guidance. Each fibroid is heated to temperatures averaging 95 deg C. The fibroid undergoes coagulative necrosis and shrinks and/or disappears.

Global Fibroid Ablation (GFA)

Myomectomy is a procedure in which an incision is made into the uterus and the fibroids are surgically removed from the uterus. The uterine incision is closed with sutures. This procedure can be performed through an abdominal incision or via laparoscopy.

Abdominal or Laparoscopic Myomectomy

UAE is a minimally invasive surgical procedure used to treat uterine fibroids. An embolic material is injected into the uterine artery(ies) to block blood flow to one or more fibroids. This procedure is performed by an interventional radiologist.

Uterine Artery Embolization (UAE)

David Eisenstein, MD

This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids. In addition, data from this study is being used to satisfy the requirements of the United States Food and Drug Administration's 522 (post market surveillance) order.

The purpose of this study is to 1) evaluate the economic burden, safety and outcomes of three uterine-conserving treatment alternatives for symptomatic uterine fibroids: myomectomy, uterine artery embolization (UAE), and global fibroid ablation (GFA) using the Acessa™ System, and 2) meet the requirements of the U.S. Food and Drug Administration's 522 Order for post market surveillance In this study, subjects who have symptomatic uterine fibroids will be randomized to one of three uterine-conserving treatments based on the local standard of care.

Post Market TRUST - U.S.A. Study

The TRUST (Treatment Results of Uterine Sparing Technologies) U.S.A. Study

To compare medical, surgical, and hospitalization costs (including procedural complication costs) of Global Fibroid Ablation (GFA) compared to those of Myomectomy and Uterine Artery Embolization (UAE)at 3 months post procedure.

Overall rates of acute (within 48 hours post procedure) and near-term (between 2 and 30 days post procedure) serious complications in all GFA subjects compared to the acute and near-term treatment-related serious adverse event rates in the pivotal study.

Safety measures will be assessed by comparing the complication and reintervention rate for all three alternatives (GFA, Myomectomy, UAE).

Compare incidence costs of post discharge procedure-related complications and re-interventions we well as indirect cost factors defined as days to return-to-work, return to normal activities of daily living, and cost of care up to 60 months post discharge.

To compare fibroid symptom severity and quality of life scores at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool.

Compare subjects menstrual bleeding pre-treatment and up to 3, 6, 12, 24, 36, 48, and 60 months post treatment using the Menorrhagia Impact Questionnaire (MIQ).

Assess the subject's satisfaction with her assigned procedure at 12 months post procedure using the Overall Treatment Effect questionnaire

General health outcome evaluation at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the EuroQol (EQ-5D), a standardized instrument for use as a measure of health outcome

The incidence of acute and near-term serious complications following the GFA cases will also be analyzed by investigator-surgeon during the training and post training periods..

Acessa Health, Inc.

Acessa Procedure without the use of Targeting Animation Guidance

Acessa Procedure with Targeting Animation Guidance

Acessa Procedure

Donald I Galen, MD

The purpose of this study is to test both user preference and speed of targeting with the use of the Acessa System with Targeting Animation Guidance (TAG).

The intent of the TAG system is to assist the gynecologist in getting the tip of the Acessa Handpiece to the fibroid by creating an animated image overlay of the movements and placement.

The study will be conducted in two parts:

Part 1: User Preference Testing - users will be presented with various statements pertaining to the features of the system and asked to indicate their degree of agreement.

Part 2: Time to target - will be measure by fibroid.

Post Market Evaluation of Acessa With TAG

Post Market Evaluation of the Acessa System With Targeting Animation Guidance (TAG)

Physician preference testing is assessed by the completion of a questionnaire using a 5 point rating system ranging from "strongly agree" (a rating of 5) to "strongly disagree" (a rating of 1) regarding the use of the TAG system. The questions included are in regards to ease of targeting, ease of visualizing the target, the addition of specific features that enhance user interface and the overall set-up.

To measure difference in time to target with and without the use of TAG. This is a time and motion study, with time measured at each stage of the procedure. The most important subject variable to consider was number of fibroids targeted, which influenced overall procedure time.

Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.

Acessa Procedure without the use of Targeting Animation Guidance

Acessa Procedure: Acessa Procedure

Acessa Procedure w/o TAG

Acessa Procedure with Targeting Animation Guidance

Acessa Procedure: Acessa Procedure

Acessa Procedure With TAG

Total

Age, Continuous

Sex: Female, Male

Laura Kemp, Clinical Affairs Consultant

Transducer and handpiece dynamic animation was

The use of TAG enabled the ability to reach the fi

Knowing the handpiece trajectory helped to tar

The transducer and handpiece dynamic animation hel

The use of TAG provided confidence when targeting

All subjects in whom TAG was used as an accessory system. This outcome measure was specific to this arm of the study only. Physicians provided feedback regarding use of the accessory system but did not provide feedback regarding the standard system without guidance. Physicians rated the system on a scale of 1 Strongly disagree to 5 Strongly agree.

Physician Feedback Regarding TAG System Use During Surgery.

All participants undergoing treatment with Acessa (with or without targeting animation guidance).

Number of Minutes From Visualizing the Target to Reaching the Target

All subjects followed for 1 to 2 months post treatment.

Recovery Time

Overall Study

This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or Myomectomy (laparoscopic or abdominal).

This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or uterine artery embolization (UAE).

GFA is being used for the treatment of symptomatic uterine fibroids

Myomectomy is a procedure in which uterine fibroids are surgically removed from the uterus.

UAE is a minimally invasive surgical procedure used to treat uterine fibroids.

John Thiel, MD

This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.

Uterine fibroids are the most common pelvic neoplasms in women; they severely impact quality of life and are the leading indication for hysterectomy. Hysterectomy is the definitive treatment for myomas; however, many patients seek alternative uterine-sparing therapy and desire to conserve their fertility. Myomectomy is a much-reported surgical option for women with symptomatic fibroids and, until recently, the abdominal approach has been the approach of choice for most surgeons. Over time, patients have requested less invasive procedures and minimally invasive, laparoscopic options are becoming more popular among patients and their gynecologists. Standard surgical and interventional treatments for uterine fibroids are costly to society and to the health care system. New technologies such as GFA may offer a low-cost alternative to the standard treatments for symptomatic uterine fibroids in women who desire uterine conservation. This study seeks to evaluate those cost differences between three available uterine-sparing techniques and to explore the qualitative outcomes such as symptom severity, health related quality of life, and overall treatment effect.

Post Market TRUST Study

The Trust (Treatment Results of Uterine Sparing Technologies) Study

Safety measures will be assessed by comparing the complication rate for all three alternatives (GFA, Myomectomy, UAE).

To compare fibroid symptom severity and quality of life scores at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL0 assessment tool.

Compare subject's satisfaction and general health outcome at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the EQ-5D (a standardized instrument for use as a measure of health outcome).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post Market TRUST - U.S.A. Study	NCT02163525	Symptomatic Ute...	Global Fibroid ... Abdominal or La... Uterine Artery ...	18 Years -	Acessa Health, Inc.
Post Market Evaluation of Acessa With TAG	NCT01842789	Uterine Fibroid...	Acessa Procedur...	18 Years - 55 Years	Acessa Health, Inc.
Post Market TRUST - U.S.A. Study	NCT02163525	Symptomatic Ute...	Global Fibroid ... Abdominal or La... Uterine Artery ...	18 Years -	Acessa Health, Inc.
Post Market Evaluation of Acessa With TAG	NCT01842789	Uterine Fibroid...	Acessa Procedur...	18 Years - 55 Years	Acessa Health, Inc.
Post Market TRUST - U.S.A. Study	NCT02163525	Symptomatic Ute...	Global Fibroid ... Abdominal or La... Uterine Artery ...	18 Years -	Acessa Health, Inc.
Post Market TRUST Study	NCT01563783	Uterine Fibroid...	Global Fibroid ... Abdominal or La... Uterine Artery ...	18 Years -	Acessa Health, Inc.

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