Post Market Clinical Follow-up Study Venezia

April 11, 2024 updated by: Nucletron Operations BV

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University Vienna
  • Germany
      • Munich, Germany
        • Ludwig-Maximilians - University of Munich
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Centre Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be included in this study at 5 centers: 3 centers in Europe and 2 centers in the United States. For all participants chemoradiation treatment is planned with curative intent. Since chemoradiation including external beam radiation therapy and brachytherapy is standard of care for these patients, patients are selected according to the clinical practice guidelines of the clinical center. The treating radiation oncologist decides which patients will undergo the brachytherapy with the Advanced Gynecological Applicator Venezia Configuration.

Description

Inclusion Criteria:

  • Patients with locally advanced cervical cancer stage IB to IVA
  • Patients eligible for brachytherapy according to the criteria of the treating radiation oncologist and center guidelines
  • Patients that are eligible to undergo brachytherapy with the Advanced Gynecological Applicator Venezia Configuration according to the criteria of the treating radiation oncologist
  • Patient is able to understand and has voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures.

Exclusion Criteria:

  • Patients that have been treated or will be treated for cancer other than cervical cancer.
  • Advanced stage cervical cancer patients who have been treated with pelvic radiotherapy, incl. brachytherapy, before.
  • Patients younger than 18 years at the time of diagnosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment arm
Single arm study, 40 participants will undergo brachytherapy with the Advanced Gynecological Applicator Venezia Configuration
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of the AGA Venezia configuration applicator as assessed by the 'Applicator Performance Questionnaire'
Time Frame: Within one week after each individual insertion. No change is assessed. The procedure is performed per hospital standard. On average, the procedure and applicator insertions are performed twice.
Performance of the device is assessed via the 'Applicator Performance Questionnaire' completed by the radiation oncologist. Scale is as follows: Completely Agree/Agree/Neutral/Disagree/Completely Disagree/Not Applicable. The primary endpoint, the third question ('I am able to deliver conformal dose to the tumor target volume while effectively avoiding the organs at risk') on the Questionnaire will be summarized through descriptive statistics in general summary tables. Additionally, responses will be recoded numerically ('Completely agree' = 1, 'Agree' = 2, 'Neutral' = 3, 'Disagree' = 4, and 'Completely disagree' = 5). A five-number summary (min, first quartile, median, third quartile and max) and a boxplot will be shown. The question will also be recoded as success ('Completely agree'&'Agree') and failure ('Neutral', 'Disagree' & 'Completely disagree').
Within one week after each individual insertion. No change is assessed. The procedure is performed per hospital standard. On average, the procedure and applicator insertions are performed twice.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risks and/or complications of the AGA Venezia configuration applicator as assessed by the 'Risks and Complications Questionnaire'
Time Frame: Immediately after each insertion and followed up during the first follow-up visit, typically three months after the last insertion. The procedure is performed per hospital standard. On average, the procedure and applicator insertions are performed twice.
Unknown risks or complications are assessed via the 'Risks and Complications Questionnaire' completed by the treating radiation oncologist. The treating radiation oncologist will be asked to complete this questionnaires to assess whether risks and complications occurred or not. There is no scale, but answer options include yes/no. The value "NO" is considered a better outcome. "YES" constitutes the worst outcome. Descriptive statistics presented in general summary tables will be provided, summarizing the number of non-missing observations (n), mean, standard deviation, minimum, median and maximum for quantitative data. For categorical data, frequency counts and percentages will be determined.
Immediately after each insertion and followed up during the first follow-up visit, typically three months after the last insertion. The procedure is performed per hospital standard. On average, the procedure and applicator insertions are performed twice.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nucletron Operations BV

Collaborators

Factory CRO

Investigators

  • Principal Investigator: Ina Jurgenliemk-Schulz, MD, PhD, UMC Utrecht
  • Principal Investigator: Alina Sturdza, MD, Medical University Vienna
  • Principal Investigator: Robert Hobbs, MD, Johns Hopkins University
  • Principal Investigator: Elizabeth Harris, MD, University Hospital Case Western
  • Principal Investigator: Stefanie Corradini, Dr. med., Ludwig-Maximilians - University of Munich
  • Study Chair: Ina Jurgenliemk-Schulz, MD, PhD, UMC Utrecht
  • Study Chair: Christian Kirisits, Prof. Dr., Medical University Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2019

Primary Completion (Actual)

July 26, 2021

Study Completion (Actual)

May 3, 2022

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Venezia-CIP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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