NCT01842789

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 19, 2017

Completed
Last Updated

August 18, 2017

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

April 17, 2013

Results QC Date

May 27, 2017

Last Update Submit

July 18, 2017

Conditions

Uterine Fibroids

Keywords

AcessaFibroidsHaltTargeting AnimationImage OverlayRadiofrequency AblationRFA

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Intraoperative

Secondary Outcomes (1)

  • Recovery Time

    1 to 2 months

Study Arms (2)

Acessa Procedure w/o TAG

OTHER

Acessa Procedure without the use of Targeting Animation Guidance

Device: Acessa Procedure

Acessa Procedure with TAG

OTHER

Acessa Procedure with Targeting Animation Guidance

Device: Acessa Procedure

Interventions

Acessa ProcedureDEVICE

Acessa Procedure

Also known as: TAG, Halt Procedure, GFA
Acessa Procedure w/o TAGAcessa Procedure with TAG

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Are planning to undergo the Acessa procedure
  • Are willing and able to comply with all procedures
  • Are capable of providing informed consent

You may not qualify if:

  • In the medical judgement of the investigator should not participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Donald I Galen Consulting

San Ramon, California, 94583, United States

Location

Related Publications (12)

  • 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.

    PMID: 19326991BACKGROUND

  • Fried MP, Parikh SR, Sadoughi B. Image-guidance for endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1287-92. doi: 10.1097/MLG.0b013e31816bce76.

    PMID: 18391767BACKGROUND

  • 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.

    PMID: 17804777BACKGROUND

  • 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.

    PMID: 21545960BACKGROUND

  • 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.

    PMID: 15746670BACKGROUND

  • 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.

    PMID: 16502165BACKGROUND

  • 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.

    PMID: 23073229BACKGROUND

  • 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.

    BACKGROUND

  • Lee BB. Radiofrequency ablation of uterine fibroids; a new minimally invasive hysterectomy alternative. Obstet Gynecol. 2002;99(Suppl):S9.

    BACKGROUND

  • 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.

    PMID: 23635746BACKGROUND

  • Macer JA. For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation. obmanagement.com Vol 25 No. 11 November 2013

    BACKGROUND

  • 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.

    PMID: 26471917RESULT

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Results Point of Contact

Title
Laura Kemp, Clinical Affairs Consultant
Organization
Acessa Health, Inc.
lkemp@acessahealth.com
4083751465

Study Officials

  • Donald I Galen, MD

    Donald I Galen Consulting

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 30, 2013

Study Start

April 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 18, 2017

Results First Posted

July 19, 2017

Record last verified: 2016-02

Locations

US(1)