Post Market Clinical Follow-up Study Venezia

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958357
• Other study ID #: Venezia-CIP-001
• Status: Completed
• Start date: April 10, 2019
• Est. completion date: May 3, 2022

Study information

• Verified date: September 2020
• Source: Nucletron Operations BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 3, 2022
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna
Germany	Ludwig-Maximilians - University of Munich	Munich
Netherlands	University Medical Centre Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Nucletron Operations BV	Factory CRO

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of the AGA Venezia configuration applicator as assessed by the 'Applicator Performance Questionnaire'	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	Risks and/or complications of the AGA Venezia configuration applicator as assessed by the 'Risks and Complications Questionnaire'	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.