An interventional study of Acessa Procedure in Uterine Fibroids, sponsored by Acessa Health, Inc.. Terminated at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-18.
Sponsored by Acessa Health, Inc. · Not applicable, Interventional, and Other
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 18 is below the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Acessa Health, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Women who:
Exclusion Criteria: Women who:
Acessa Procedure without the use of Targeting Animation Guidance
Device: Acessa Procedure
Acessa Procedure with Targeting Animation Guidance
Device: Acessa Procedure
Acessa Procedure
Also known as: TAG, Halt Procedure, GFA
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
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
Recovery Time
Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.
Time frame: 1 to 2 months
| Milestone | Acessa Procedure w/o TAG | Acessa Procedure With TAG |
|---|---|---|
| Started | 10 | 8 |
| Completed | 10 | 8 |
| Not completed | 0 | 0 |
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.
| units on a scale | Acessa Procedure With TAG |
|---|---|
| Transducer and handpiece dynamic animation was | 5.0 ± 0 |
| The use of TAG enabled the ability to reach the fi | 5.0 ± 0 |
| Knowing the handpiece trajectory helped to tar | 5.0 ± 0 |
| The transducer and handpiece dynamic animation hel | 4.7 ± 0.46 |
| The use of TAG provided confidence when targeting | 4.9 ± 0.35 |
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.
| Minutes per fibroid treated | Acessa Procedure w/o TAG | Acessa Procedure With TAG |
|---|---|---|
| Number of Minutes From Visualizing the Target to Reaching the Target | 29.9 (8.9 to 65.0) | 25.2 (15.1 to 45.0) |
Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.
| days | Acessa Procedure w/o TAG | Acessa Procedure With TAG |
|---|---|---|
| Recovery Time | 8.5 (2 to 45) | 6 (4 to 21) |
Collected over 30 days post operative follow up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acessa Procedure w/o TAG | — | 0/10 (0%) | 0/10 (0%) |
| Acessa Procedure With TAG | — | 1/8 (12.5%) | 1/8 (12.5%) |
| Event | Acessa Procedure w/o TAG | Acessa Procedure With TAG |
|---|---|---|
| Bowel obstructionGastrointestinal disorders | 0/10 | 1/8 |
| Event | Acessa Procedure w/o TAG | Acessa Procedure With TAG |
|---|---|---|
| Poor wound healingSkin and subcutaneous tissue disorders | 0/10 | 1/8 |
| Age, Continuous(Years) | Acessa Procedure w/o TAG | Acessa Procedure With TAG | Total |
|---|---|---|---|
| Mean | 41.8 (28.5 to 49.6) | 43.9 (31.2 to 52.9) | 42.7 (28.5 to 52.9) |
| Sex: Female, Male(Participants) | Acessa Procedure w/o TAG | Acessa Procedure With TAG | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 0 | 0 | 0 |
This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Acessa Health, Inc.