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| Name | Class |
|---|---|
| Factory CRO | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Single arm study, 40 participants will undergo brachytherapy with the Advanced Gynecological Applicator Venezia Configuration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Participants with cervical cancer
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Vienna | Austria | ||||
| Ludwig-Maximilians - University of Munich |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| 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. |
| Munich |
| Germany |
| University Medical Centre Utrecht | Utrecht | 3584 CX | Netherlands |
| D002577 |
| Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |