Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT02007005
Eligibility Criteria:
Inclusion Criteria:
* Patients with clinically proved superficial bladder cancer (Ta G1/G2 or T1G1/G2) 2 - 7 weeks before transurethral resection
* Written informed consent for study participation and for documentation of disease data including further distribution of these data
Exclusion Criteria:
* Muscle invasive bladder carcinoma and/or carcinoma in situ (CIS)
* Intravesical instillation therapy within 6 months prior to study enrolment
* Radiotherapy of the bladder prior to study enrolment
* Contracted bladder (capacity less than 100 ml)
* Non treated acute or chronic urinary tract infection
* Allergy against mistletoe extract preparations
* Subvesical obstructions (e. g. prostate hyperplasia, urethral stenosis, residual urine volume more than 80 ml)
* Severe illnesses and circumstances not permitting study participation (e. g. alcoholism or substance abuse)
* Pregnancy or lactation (pregnancy test if required) as well as women without sufficient contraception
* Participation in another clinical study within 30 days prior to this study
* Administration of immunotherapeutic and/or cytostatic drugs within 4 weeks prior to study enrolment
* Chronic progressive infections (e. g. tuberculosis)
* Pre-treatment with mistletoe extracts/mistletoe lectins
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02007005
Study Brief:
Protocol Section:
NCT02007005