Clinical trial · Observational
Post Market Clinical Follow-up Study Venezia
Multi-center Prospective Observational Clinical Follow-Up Study Advanced Gynecological Applicator - Venezia Configuration
NCT03958357CI-TRIAL-00075978completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Advanced Gynecological Applicator configuration | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Treatment arm
- description
- Single arm study, 40 participants will undergo brachytherapy with the Advanced Gynecological Applicator Venezia Configuration
- interventionNames
- Device: Advanced Gynecological Applicator configuration
Primary outcomes (1)
- measure
- Performance of the AGA Venezia configuration applicator as assessed by the 'Applicator Performance Questionnaire'
- timeFrame
- 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.
- description
- 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').
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.