Post Market Clinical Follow-up Study Venezia

NCT03958357 | Completed FDA Device

• 1 other identifier: Venezia-CIP-001
• Study Type: observational
• Target: 41
• Locations: 3 countries
• Sites: 3

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.

Conditions

Cervical Cancer

Keywords

Cervix; Uterus; Vagina; Cancer; Gynecology; Cervical cancer; External beam radiation therapy; Brachytherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Treatment arm

Single arm study, 40 participants will undergo brachytherapy with the Advanced Gynecological Applicator Venezia Configuration

Device: Advanced Gynecological Applicator configuration

Interventions

Advanced Gynecological Applicator configuration DEVICE

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.

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants with cervical cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nucletron Operations BV: lead
• Factory CRO: collaborator

Study Sites (3)

Medical University Vienna

Vienna, Austria

Location

Ludwig-Maximilians - University of Munich

Munich, Germany

Location

University Medical Centre Utrecht

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Ina Jurgenliemk-Schulz, MD, PhD

  UMC Utrecht

  STUDY CHAIR

• Christian Kirisits, Prof. Dr.

  Medical University Vienna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 22, 2019
• Study Start: April 10, 2019
• Primary Completion: July 26, 2021
• Study Completion: May 3, 2022
• Last Updated: April 12, 2024

Record last verified: 2020-09

Locations

AU (1); DE (1); NL (1)