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Post Market Clinical Follow-up Study Venezia

NCT03958357 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2024-04-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Factory CRO

    collaborator INDUSTRY

  • Nucletron Operations BV

    lead INDUSTRY

Principal Investigators

  • Ina Jurgenliemk-Schulz, MD, PhD · UMC Utrecht

  • Alina Sturdza, MD · Medical University Vienna

  • Robert Hobbs, MD · Johns Hopkins University

  • Elizabeth Harris, MD · University Hospital Case Western

  • Stefanie Corradini, Dr. med. · Ludwig-Maximilians - University of Munich

  • Ina Jurgenliemk-Schulz, MD, PhD · UMC Utrecht

  • Christian Kirisits, Prof. Dr. · Medical University Vienna

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2021-07-26
Completion
2022-05-03
FDA Device
Yes

Countries

  • Austria
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03958357 on ClinicalTrials.gov