Post Market Clinical Follow-up Study Venezia

Completed

• Conditions: Cervical Cancer
• Interventions: Device: Advanced Gynecological Applicator configuration

• Registration Number: NCT03958357
• Lead Sponsor: Nucletron Operations BV

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.

Study Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-22
• Status Verified: 2020-09
• Primary Completion: 2021-07-26
• Study Completion: 2022-05-03
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment arm	Advanced Gynecological Applicator configuration	Single arm study, 40 participants will undergo brachytherapy with the Advanced Gynecological Applicator Venezia Configuration

Primary Outcome Measures

Name	Time	Method
Performance of the AGA Venezia configuration applicator as assessed by the 'Applicator Performance Questionnaire'	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').

Secondary Outcome Measures

Name	Time	Method
Risks and/or complications of the AGA Venezia configuration applicator as assessed by the 'Risks and Complications Questionnaire'	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.

Trial Locations

Locations (3)

Medical University Vienna; 🇦🇹 Vienna, Austria

Ludwig-Maximilians - University of Munich; 🇩🇪 Munich, Germany

University Medical Centre Utrecht; 🇳🇱 Utrecht, Netherlands