Uterine FibroidsTAGNCT01842789

Post Market Evaluation of Acessa With TAG

A study testing Acessa Procedure in people with Uterine Fibroids, run by Acessa Health, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Uterine Fibroids
What is being tested?: Acessa Procedure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Apr 2013to Feb 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Donald I Galen Consulting
San Ramon, California, 94583

Other trials in United States

About this study

Official title: Post Market Evaluation of the Acessa System With Targeting Animation Guidance (TAG)

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).

Read the 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.

Conditions: Uterine Fibroids
Being tested: Acessa Procedure
Keywords: Acessa, Fibroids, Halt, Targeting Animation, Image Overlay, Radiofrequency Ablation, RFA
Medical subject headings: Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acessa ProcedureDevice
Also called TAG, Halt Procedure, GFA
Acessa Procedure

Study groups in NCT01842789
Study group	Role	What they receive
Acessa Procedure w/o TAG	Other	Acessa Procedure without the use of Targeting Animation Guidance Receives: Device: Acessa Procedure
Acessa Procedure with TAG	Other	Acessa Procedure with Targeting Animation Guidance Receives: Device: Acessa Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Intraoperative

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Feb 2016

First posted30 Apr 2013 (estimated)
Study startApr 2013
Primary completionFeb 2016
Study completionFeb 2016

Why it stopped: Results to date adequately demonstrated user preference and recovery time. Time to target (Part II) was not studied. .

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Uterine FibroidsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01842789
Sponsor's protocol ID: CP-00-0021
Acronym: TAG
Status last verified: Feb 2016
First submitted: 17 Apr 2013
Last updated: 18 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19326991
Fried MP, Parikh SR, Sadoughi B. Image-guidance for endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1287-92. doi: 10.1097/MLG.0b013e31816bce76.
PubMed 18391767
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.
PubMed 17804777
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.
PubMed 21545960
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.
PubMed 15746670
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.
PubMed 16502165
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.
PubMed 23073229
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.
Lee BB. Radiofrequency ablation of uterine fibroids; a new minimally invasive hysterectomy alternative. Obstet Gynecol. 2002;99(Suppl):S9.
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.
PubMed 23635746
Macer JA. For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation. obmanagement.com Vol 25 No. 11 November 2013
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.
PubMed 26471917

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy

All Uterine Fibroids trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Market Evaluation of the Acessa System With Targeting Animation Guidance (TAG)
ClinicalTrials.gov ID: NCT01842789
Acronym / sponsor ID: TAG / CP-00-0021
Conditions: Uterine Fibroids
Keywords: Acessa, Fibroids, Halt, Targeting Animation, Image Overlay, Radiofrequency Ablation, RFA
Study type: Interventional
Recruitment status: TerminatedReason stopped: Results to date adequately demonstrated user preference and recovery time. Time to target (Part II) was not studied. .
Enrolment: 18 participants (actual)
Lead sponsor: Acessa Health, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 30 Apr 2013 (estimated)
Results: Posted 19 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Acessa Procedure w/o TAG	Other	Device: Acessa ProcedureAcessa Procedure without the use of Targeting Animation Guidance
Acessa Procedure with TAG	Other	Device: Acessa ProcedureAcessa Procedure with Targeting Animation Guidance

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acessa ProcedureAlso: TAG, Halt Procedure, GFAAcessa Procedure	Device	Acessa Procedure w/o TAG, Acessa Procedure with TAG

Primary outcome

Physician Feedback Regarding TAG System Use During Surgery.
Time frame: 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
Time frame: 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.

1 secondary outcome

Recovery Time
Time frame: 1 to 2 months

Results and safety

Results posted to the registry on 19 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acessa Procedure w/o TAG	10	10
Acessa Procedure With TAG	8	8

Primary outcome: Physician Feedback Regarding TAG System Use During Surgery.

Time frame: Physicians have up to 1 hour after the procedure to fill out the questionnaire. Mean (Standard Deviation). Unit: units on a scale

Measure	Acessa Procedure With TAG n = 8
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)

Population analysed: 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.

Primary outcome: Number of Minutes From Visualizing the Target to Reaching the Target

Time frame: Intraoperative. Mean (Full Range). Unit: Minutes per fibroid treated

Measure	Acessa Procedure w/o TAG n = 10	Acessa Procedure With TAG n = 8
Value	29.9 (8.9 to 65.0)	25.2 (15.1 to 45.0)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 days post operative follow up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acessa Procedure w/o TAG	0 of 10 (0%)	0 of 10 (0%)	Not reported
Acessa Procedure With TAG	1 of 8 (12.5%)	1 of 8 (12.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19326991Hayhurst 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.
Background: PubMed 18391767Fried MP, Parikh SR, Sadoughi B. Image-guidance for endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1287-92. doi: 10.1097/MLG.0b013e31816bce76.
Background: PubMed 17804777Krucker 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.
Background: PubMed 21545960Garza 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.
Background: PubMed 15746670Bergamini 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.
Background: PubMed 16502165Milic 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.
Background: PubMed 23073229Robles 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.
BackgroundChudnoff 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.
BackgroundLee BB. Radiofrequency ablation of uterine fibroids; a new minimally invasive hysterectomy alternative. Obstet Gynecol. 2002;99(Suppl):S9.
Background: PubMed 23635746Chudnoff 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.
BackgroundMacer JA. For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation. obmanagement.com Vol 25 No. 11 November 2013
Results publication: PubMed 26471917Galen 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.

Related trials for Uterine Fibroids

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
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Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donald I Galen, MD principal investigator

Donald I Galen Consulting

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acessa Procedure in people with Uterine Fibroids, run by Acessa Health, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physician Feedback Regarding TAG System Use During Surgery. (time frame: Physicians have up to 1 hour after the procedure to fill out the questionnaire). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01842789, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.