Clinical trial · Interventional
Post Market Evaluation of Acessa With TAG
Post Market Evaluation of the Acessa System With Targeting Animation Guidance (TAG)
NCT01842789CI-TRIAL-00029147TAGterminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Results to date adequately demonstrated user preference and recovery time. Time to target (Part II) was not studied. .
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acessa Procedure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Acessa Procedure w/o TAG
- description
- Acessa Procedure without the use of Targeting Animation Guidance
- interventionNames
- Device: Acessa Procedure
- type
- OTHER
- label
- Acessa Procedure with TAG
- description
- Acessa Procedure with Targeting Animation Guidance
- interventionNames
- Device: Acessa Procedure
Primary outcomes (2)
- measure
- Physician Feedback Regarding TAG System Use During Surgery.
- timeFrame
- Physicians have up to 1 hour after the procedure to fill out the questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (12)
- BACKGROUNDHayhurst 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 19326991
- BACKGROUNDFried MP, Parikh SR, Sadoughi B. Image-guidance for endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1287-92. doi: 10.1097/MLG.0b013e31816bce76. PMID 18391767
- BACKGROUNDKrucker 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 17804777
- BACKGROUNDGarza 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 21545960
- BACKGROUNDBergamini 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 15746670
- BACKGROUNDMilic 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 16502165
- BACKGROUNDRobles 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.