NCT03958357

Post Market Clinical Follow-up Study Venezia

Multi-center Prospective Observational Clinical Follow-Up Study Advanced Gynecological Applicator - Venezia Configuration

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Nucletron Operations BV · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DEVICE	Advanced Gynecological Applicator configuration	The Advanced Gynecological Applicator Venezia configuration is a gynaecological applicator for intracavitary and interstitial brachytherapy. The applicator consists of tubes, caps and templates to place needles, which can be combined to reach a wide range of target areas. The tubes and possibly used needles, guide the radioactive source of the afterloader to the target volume. Dose optimization and dose fractionation is performed with the goal of adapting the dose to the target volume without exceeding the dose volume constraints for the surrounding normal tissues according to the standard cervical cancer treatment of the centre.

Timeline

• Start date: 2019-04-10
• Primary completion: 2021-07-26
• Completion: 2022-05-03
• First posted: 2019-05-22
• Last updated: 2024-04-12

Locations

3 sites across 3 countries: Austria, Germany, Netherlands

Regulatory

• FDA-regulated device study