{
"info": {
"nct_id": "NCT04712201",
"official_title": "En Bloc Bladder Tumor Resection: Prospective Randomized Evaluation of Monopolar, Bipolar and Laser Energy",
"inclusion_criteria": "* Unifocal primary or recurrent bladder cancer with size less or equal than 3 cm\n* Multifocal primary or recurrent bladder cancer less or equal than 3 lesions and with size less or equal than 3 cm\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Evidence of > 3 tumors or > 3 cm\n* Computed tomography/cystoscopy suspect of muscle-invasive bladder cancer (cT2 or higher)\n* Computed tomography/magnetic resonance evidence of distant metastases",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Unifocal primary or recurrent bladder cancer with size less or equal than 3 cm",
"criterions": [
{
"exact_snippets": "Unifocal primary or recurrent bladder cancer",
"criterion": "bladder cancer",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"unifocal primary",
"recurrent"
]
}
]
},
{
"exact_snippets": "size less or equal than 3 cm",
"criterion": "tumor size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "cm"
}
}
]
}
]
},
{
"line": "* Multifocal primary or recurrent bladder cancer less or equal than 3 lesions and with size less or equal than 3 cm",
"criterions": [
{
"exact_snippets": "Multifocal primary or recurrent bladder cancer",
"criterion": "bladder cancer",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"multifocal primary",
"recurrent"
]
}
]
},
{
"exact_snippets": "less or equal than 3 lesions",
"criterion": "number of lesions",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "lesions"
}
}
]
},
{
"exact_snippets": "size less or equal than 3 cm",
"criterion": "lesion size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "cm"
}
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Evidence of > 3 tumors or > 3 cm",
"criterions": [
{
"exact_snippets": "Evidence of > 3 tumors",
"criterion": "tumors",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "N/A"
}
}
]
},
{
"exact_snippets": "Evidence of ... > 3 cm",
"criterion": "tumor size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "cm"
}
}
]
}
]
},
{
"line": "* Computed tomography/cystoscopy suspect of muscle-invasive bladder cancer (cT2 or higher)",
"criterions": [
{
"exact_snippets": "Computed tomography/cystoscopy suspect of muscle-invasive bladder cancer",
"criterion": "muscle-invasive bladder cancer",
"requirements": [
{
"requirement_type": "suspicion",
"expected_value": true
}
]
},
{
"exact_snippets": "cT2 or higher",
"criterion": "tumor stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "cT"
}
}
]
}
]
},
{
"line": "* Computed tomography/magnetic resonance evidence of distant metastases",
"criterions": [
{
"exact_snippets": "Computed tomography/magnetic resonance evidence of distant metastases",
"criterion": "distant metastases",
"requirements": [
{
"requirement_type": "evidence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}