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Post Market Evaluation of Acessa With TAG (TAG)

Primary Purpose

Uterine Fibroids

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acessa Procedure
Sponsored by
Acessa Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Uterine Fibroids focused on measuring Acessa, Fibroids, Halt, Targeting Animation, Image Overlay, Radiofrequency Ablation, RFA

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Donald I Galen Consulting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Acessa Procedure w/o TAG

Acessa Procedure with TAG

Arm Description

Acessa Procedure without the use of Targeting Animation Guidance

Acessa Procedure with Targeting Animation Guidance

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 17, 2013
Last Updated
July 18, 2017
Sponsor
Acessa Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01842789
Brief Title
Post Market Evaluation of Acessa With TAG
Acronym
TAG
Official Title
Post Market Evaluation of the Acessa System With Targeting Animation Guidance (TAG)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Results to date adequately demonstrated user preference and recovery time. Time to target (Part II) was not studied. .
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acessa Health, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Acessa, Fibroids, Halt, Targeting Animation, Image Overlay, Radiofrequency Ablation, RFA

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acessa Procedure w/o TAG
Arm Type
Other
Arm Description
Acessa Procedure without the use of Targeting Animation Guidance
Arm Title
Acessa Procedure with TAG
Arm Type
Other
Arm Description
Acessa Procedure with Targeting Animation Guidance
Intervention Type
Device
Intervention Name(s)
Acessa Procedure
Other Intervention Name(s)
TAG, Halt Procedure, GFA
Intervention Description
Acessa Procedure
Primary Outcome Measure Information:
Title
Physician Feedback Regarding TAG System Use During Surgery.
Description
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
Title
Number of Minutes From Visualizing the Target to Reaching the Target
Description
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
Secondary Outcome Measure Information:
Title
Recovery Time
Description
Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.
Time Frame
1 to 2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald I Galen, MD
Organizational Affiliation
Donald I Galen Consulting
Official's Role
Principal Investigator
Facility Information:
Facility Name
Donald I Galen Consulting
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19326991
Citation
Hayhurst C, Byrne P, Eldridge PR, Mallucci CL. Application of electromagnetic technology to neuronavigation: a revolution in image-guided neurosurgery. J Neurosurg. 2009 Dec;111(6):1179-84. doi: 10.3171/2008.12.JNS08628.
Results Reference
background
PubMed Identifier
18391767
Citation
Fried MP, Parikh SR, Sadoughi B. Image-guidance for endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1287-92. doi: 10.1097/MLG.0b013e31816bce76.
Results Reference
background
PubMed Identifier
17804777
Citation
Krucker J, Xu S, Glossop N, Viswanathan A, Borgert J, Schulz H, Wood BJ. Electromagnetic tracking for thermal ablation and biopsy guidance: clinical evaluation of spatial accuracy. J Vasc Interv Radiol. 2007 Sep;18(9):1141-50. doi: 10.1016/j.jvir.2007.06.014.
Results Reference
background
PubMed Identifier
21545960
Citation
Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Lee BB. Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System. J Minim Invasive Gynecol. 2011 May-Jun;18(3):364-71. doi: 10.1016/j.jmig.2011.02.006.
Results Reference
background
PubMed Identifier
15746670
Citation
Bergamini V, Ghezzi F, Cromi A, Bellini G, Zanconato G, Scarperi S, Franchi M. Laparoscopic radiofrequency thermal ablation: a new approach to symptomatic uterine myomas. Am J Obstet Gynecol. 2005 Mar;192(3):768-73. doi: 10.1016/j.ajog.2004.10.591.
Results Reference
background
PubMed Identifier
16502165
Citation
Milic A, Asch MR, Hawrylyshyn PA, Allen LM, Colgan TJ, Kachura JR, Hayeems EB. Laparoscopic ultrasound-guided radiofrequency ablation of uterine fibroids. Cardiovasc Intervent Radiol. 2006 Jul-Aug;29(4):694-8. doi: 10.1007/s00270-005-0045-9.
Results Reference
background
PubMed Identifier
23073229
Citation
Robles R, Aguirre VA, Argueta AI, Guerrero MR. Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up. Int J Gynaecol Obstet. 2013 Jan;120(1):65-9. doi: 10.1016/j.ijgo.2012.07.023. Epub 2012 Oct 14.
Results Reference
background
Citation
Chudnoff SG, Levine DJ, Galen DI, et al. Prospective 12-month follow up of quality-of-life improvement following 135 consecutive cases laparoscopic and ultrasound-guided radiofrequency ablation of fibroids. J Minim Invasive Gynecol. 2012;19(Suppl):S45.
Results Reference
background
Citation
Lee BB. Radiofrequency ablation of uterine fibroids; a new minimally invasive hysterectomy alternative. Obstet Gynecol. 2002;99(Suppl):S9.
Results Reference
background
PubMed Identifier
23635746
Citation
Chudnoff SG, Berman JM, Levine DJ, Harris M, Guido RS, Banks E. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol. 2013 May;121(5):1075-1082. doi: 10.1097/AOG.0b013e31828b7962.
Results Reference
background
Citation
Macer JA. For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation. obmanagement.com Vol 25 No. 11 November 2013
Results Reference
background
PubMed Identifier
26471917
Citation
Galen DI. Electromagnetic image guidance in gynecology: prospective study of a new laparoscopic imaging and targeting technique for the treatment of symptomatic uterine fibroids. Biomed Eng Online. 2015 Oct 15;14:90. doi: 10.1186/s12938-015-0086-5.
Results Reference
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Post Market Evaluation of Acessa With TAG

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