Trial Outcomes & Findings for Post Market Evaluation of Acessa With TAG (NCT NCT01842789)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Physicians have up to 1 hour after the procedure to fill out the questionnaire

Results posted on

2017-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Acessa Procedure w/o TAG Acessa Procedure without the use of Targeting Animation Guidance Acessa Procedure: Acessa Procedure	Acessa Procedure With TAG Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure
Overall Study STARTED	10	8
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post Market Evaluation of Acessa With TAG

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acessa Procedure w/o TAG n=10 Participants Acessa Procedure without the use of Targeting Animation Guidance Acessa Procedure: Acessa Procedure	Acessa Procedure With TAG n=8 Participants Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure	Total n=18 Participants Total of all reporting groups
Age, Continuous	41.8 Years n=5 Participants	43.9 Years n=7 Participants	42.7 Years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Acessa Procedure With TAG n=8 Participants Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure	Acessa Procedure With TAG Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure
Physician Feedback Regarding TAG System Use During Surgery. Transducer and handpiece dynamic animation was	5.0 units on a scale Standard Deviation 0	—
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	—
Physician Feedback Regarding TAG System Use During Surgery. Knowing the handpiece trajectory helped to tar	5.0 units on a scale Standard Deviation 0	—
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	—
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	—

PRIMARY outcome

Timeframe: Intraoperative

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

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.

Outcome measures

Outcome measures
Measure	Acessa Procedure With TAG n=10 Participants Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure	Acessa Procedure With TAG n=8 Participants Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure
Number of Minutes From Visualizing the Target to Reaching the Target	29.9 Minutes per fibroid treated Interval 8.9 to 65.0	25.2 Minutes per fibroid treated Interval 15.1 to 45.0

SECONDARY outcome

Timeframe: 1 to 2 months

Population: All subjects followed for 1 to 2 months post treatment.

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

Outcome measures

Outcome measures
Measure	Acessa Procedure With TAG n=10 Participants Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure	Acessa Procedure With TAG n=6 Participants Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure
Recovery Time	8.5 days Interval 2.0 to 45.0	6 days Interval 4.0 to 21.0

Adverse Events

Acessa Procedure w/o TAG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acessa Procedure With TAG

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Acessa Procedure w/o TAG n=10 participants at risk Acessa Procedure without the use of Targeting Animation Guidance Acessa Procedure: Acessa Procedure	Acessa Procedure With TAG n=8 participants at risk Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure
Gastrointestinal disorders Bowel obstruction	0.00% 0/10 • 30 days post operative follow up	12.5% 1/8 • Number of events 1 • 30 days post operative follow up

Other adverse events

Other adverse events
Measure	Acessa Procedure w/o TAG n=10 participants at risk Acessa Procedure without the use of Targeting Animation Guidance Acessa Procedure: Acessa Procedure	Acessa Procedure With TAG n=8 participants at risk Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure
Skin and subcutaneous tissue disorders Poor wound healing	0.00% 0/10 • 30 days post operative follow up	12.5% 1/8 • 30 days post operative follow up

Additional Information

Laura Kemp, Clinical Affairs Consultant

Acessa Health, Inc.

Phone: 4083751465

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place