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Results to date adequately demonstrated user preference and recovery time. Time to target (Part II) was not studied. .
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acessa Procedure w/o TAG | Other | Acessa Procedure without the use of Targeting Animation Guidance |
|
| Acessa Procedure with TAG | Other | Acessa Procedure with Targeting Animation Guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acessa Procedure | Device | Acessa Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery Time | Patients to be followed for 1 to 2 months post-treatment to evaluate recovery. | 1 to 2 months |
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Inclusion Criteria: Women who:
Exclusion Criteria: Women who:
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| Name | Affiliation | Role |
|---|---|---|
| Donald I Galen, MD | Donald I Galen Consulting | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Donald I Galen Consulting | San Ramon | California | 94583 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19326991 | Background | 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. | |
| 18391767 | Background | Fried MP, Parikh SR, Sadoughi B. Image-guidance for endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1287-92. doi: 10.1097/MLG.0b013e31816bce76. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acessa Procedure w/o TAG | Acessa Procedure without the use of Targeting Animation Guidance Acessa Procedure: Acessa Procedure |
| FG001 | Acessa Procedure With TAG | Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acessa Procedure w/o TAG | Acessa Procedure without the use of Targeting Animation Guidance Acessa Procedure: Acessa Procedure |
| BG001 | Acessa Procedure With TAG | Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Physicians have up to 1 hour after the procedure to fill out the questionnaire |
|
30 days post operative follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acessa Procedure w/o TAG | Acessa Procedure without the use of Targeting Animation Guidance Acessa Procedure: Acessa Procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment | obstruction of the lower bowel approximately one month after the Acessa procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Poor wound healing | Skin and subcutaneous tissue disorders | For one subject, the Acessa procedure incision was found to be not healing properly approximately 10 days after the procedure. The severity of this complication was considered moderate, treated with medications, and resolved appropriately. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Kemp, Clinical Affairs Consultant | Acessa Health, Inc. | 4083751465 | lkemp@acessahealth.com |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 17804777 | Background | 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. |
| 21545960 | Background | 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. |
| 15746670 | Background | 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. |
| 16502165 | Background | 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. |
| 23073229 | Background | 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. |
| Background | 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. |
| 23635746 | 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. |
| Background | Macer JA. For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation. obmanagement.com Vol 25 No. 11 November 2013 |
| 26471917 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure |
|
|
| Primary | 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. | All participants undergoing treatment with Acessa (with or without targeting animation guidance). | Posted | Mean | Full Range | Minutes per fibroid treated | Intraoperative |
|
|
|
| Secondary | Recovery Time | Patients to be followed for 1 to 2 months post-treatment to evaluate recovery. | All subjects followed for 1 to 2 months post treatment. | Posted | Median | Full Range | days | 1 to 2 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Acessa Procedure With TAG | Acessa Procedure with Targeting Animation Guidance Acessa Procedure: Acessa Procedure | 1 | 8 | 1 | 8 |
|
|
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