Spots Global Cancer Trial Database for Post Market Clinical Follow-up Study Venezia
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Trial Identification
Brief Title: Post Market Clinical Follow-up Study Venezia
Official Title: Multi-center Prospective Observational Clinical Follow-Up Study Advanced Gynecological Applicator - Venezia Configuration
Study ID: NCT03958357
Conditions
Interventions
Study Description
Brief Summary: The investigational device is the Advanced Gynecological Applicator (AGA) Venezia configuration, an applicator to treat locally advanced stage cervical cancer. The goal of the study is to assess the performance and the unknown risks or complications of the AGA Venezia configuration during clinical use of the applicator.
Detailed Description: This is a multi-center, prospective, post-market clinical follow-up study to assess the performance and the unknown risks or complications of the Advanced Gynecological Applicator (AGA) Venezia configuration during clinical use of the applicator. The AGA Venezia configuration is a CE-marked, FDA approved and commercially available product. The AGA Venezia configuration is a gynaecological applicator for intracavitary and interstitial brachytherapy. The radiation oncologist can use it for treatment of cancers in the vagina, cervix and uterus. Forty (40) participants will be included in this study at 5 sites: 3 centers in Europe and 2 centers in the United States.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Medical University Vienna, Vienna, , Austria
Ludwig-Maximilians - University of Munich, Munich, , Germany
University Medical Centre Utrecht, Utrecht, , Netherlands
Contact Details
Name: Ina Jurgenliemk-Schulz, MD, PhD
Affiliation: UMC Utrecht
Role: PRINCIPAL_INVESTIGATOR
Name: Alina Sturdza, MD
Affiliation: Medical University Vienna
Role: PRINCIPAL_INVESTIGATOR
Name: Robert Hobbs, MD
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
Name: Elizabeth Harris, MD
Affiliation: University Hospital Case Western
Role: PRINCIPAL_INVESTIGATOR
Name: Stefanie Corradini, Dr. med.
Affiliation: Ludwig-Maximilians - University of Munich
Role: PRINCIPAL_INVESTIGATOR
Name: Ina Jurgenliemk-Schulz, MD, PhD
Affiliation: UMC Utrecht
Role: STUDY_CHAIR
Name: Christian Kirisits, Prof. Dr.
Affiliation: Medical University Vienna
Role: STUDY_CHAIR
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