Uterine Fibroids
Conditions
Keywords
Acessa, Fibroids, Halt, Targeting Animation, Image Overlay, Radiofrequency Ablation, RFA
Brief summary
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).
Detailed description
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.
Interventions
DEVICEAcessa Procedure
Acessa Procedure
Sponsors
Acessa Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Women who: * Are planning to undergo the Acessa procedure * Are willing and able to comply with all procedures * Are capable of providing informed consent
Exclusion criteria
Women who: * In the medical judgement of the investigator should not participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Feedback Regarding TAG System Use During Surgery. | Physicians have up to 1 hour after the procedure to fill out the questionnaire | 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. |
| Number of Minutes From Visualizing the Target to Reaching the Target | Intraoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Time | 1 to 2 months | Patients to be followed for 1 to 2 months post-treatment to evaluate recovery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acessa Procedure w/o TAG Acessa Procedure without the use of Targeting Animation Guidance
Acessa Procedure: Acessa Procedure | 10 |
| Acessa Procedure With TAG Acessa Procedure with Targeting Animation Guidance
Acessa Procedure: Acessa Procedure | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | Acessa Procedure w/o TAG | Acessa Procedure With TAG | Total |
|---|---|---|---|
| Age, Continuous | 41.8 Years | 43.9 Years | 42.7 Years |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 1 / 8 |
| serious Total, serious adverse events | 0 / 10 | 1 / 8 |
Outcome results
Primary
Number of Minutes From Visualizing the Target to Reaching the Target
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.
Time frame: Intraoperative
Population: All participants undergoing treatment with Acessa (with or without targeting animation guidance).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acessa Procedure With TAG | Number of Minutes From Visualizing the Target to Reaching the Target | 29.9 Minutes per fibroid treated |
| Acessa Procedure With TAG | Number of Minutes From Visualizing the Target to Reaching the Target | 25.2 Minutes per fibroid treated |
Primary
Physician Feedback Regarding TAG System Use During Surgery.
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.
Time frame: Physicians have up to 1 hour after the procedure to fill out the questionnaire
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acessa Procedure With TAG | Physician Feedback Regarding TAG System Use During Surgery. | The use of TAG enabled the ability to reach the fi | 5.0 units on a scale | Standard Deviation 0 |
| Acessa Procedure With TAG | Physician Feedback Regarding TAG System Use During Surgery. | Transducer and handpiece dynamic animation was | 5.0 units on a scale | Standard Deviation 0 |
| Acessa Procedure With TAG | Physician Feedback Regarding TAG System Use During Surgery. | Knowing the handpiece trajectory helped to tar | 5.0 units on a scale | Standard Deviation 0 |
| Acessa Procedure With TAG | Physician Feedback Regarding TAG System Use During Surgery. | The transducer and handpiece dynamic animation hel | 4.7 units on a scale | Standard Deviation 0.46 |
| Acessa Procedure With TAG | Physician Feedback Regarding TAG System Use During Surgery. | The use of TAG provided confidence when targeting | 4.9 units on a scale | Standard Deviation 0.35 |
Secondary
Recovery Time
Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.
Time frame: 1 to 2 months
Population: All subjects followed for 1 to 2 months post treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acessa Procedure With TAG | Recovery Time | 8.5 days |
| Acessa Procedure With TAG | Recovery Time | 6 days |