Post Market Evaluation of Acessa With TAG

Uterine Fibroids Clinical Trial

— TAG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01842789
• Other study ID #: CP-00-0021
• Status: Terminated
• Phase: N/A
• First received: April 17, 2013
• Last updated: February 16, 2016
• Start date: April 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Halt Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Device:
• Acessa Procedure
Acessa Procedure

Locations

Country	Name	City	State
United States	Donald I Galen Consulting	San Ramon	California

Sponsors (1)

Lead Sponsor	Collaborator
Halt Medical, Inc

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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):1075-82. doi: 10.1097/AOG.0b013e31828b7962. — View 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.

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

Krücker 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. — View Citation

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

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

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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician interface and preference with and without TAG	To obtain feedback on the user interface of the Acessa System with TAG through physician preference testing using a direct, observable human model. This will be assessed by the completion of a questionnaire using a 5 point rating system ranging from "strongly agree" to "strongly disagree" regarding the ease of targeting, specific features of the system, user interface and set-up.	Up to 1 hour post-treatment	No
Primary	Time to 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 from puncture of the serosal surface to the fibroid capsule.	Intraoperative	No
Secondary	Recovery Time	Patients to be followed 30 day post-treatment to evaluate recovery.	30 Days Post-Treatment	No