Post Market Clinical Follow-up Study Venezia

Nucletron

Status

Completed

Conditions

Cervical Cancer

Treatments

Device: Advanced Gynecological Applicator configuration

Study type

Observational

Funder types

Industry

Identifiers

NCT03958357

Venezia-CIP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.