| ID | Type | Description | Link |
|---|---|---|---|
| 16-008556 | Other Identifier | Mayo Clinic |
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The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fetal Cystoscopy Group | Experimental | Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetoscopes | Device | Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants where the procedure was technically performed | Number of participants where the fetal cystoscopy procedure was successfully technically performed. | Day 1 (Post fetal cystoscopy procedure) |
| Number of participants where the etiology of LUTO was correctly diagnosed | Number of participants where the etiology of LUTO was correctly diagnosed during fetal cystoscopy as compared to post natal cystoscopy | Up to 1 month post delivery |
| Number of participants where the posterior urethral valve were successfully released | Number of participants where the posterior urethral valve were successfully released | Day 1 (Post fetal cystoscopy procedure) |
| Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe pulmonary hypoplasia | As per treating physician evaluation of clinical assessments post-natal. | Up to 1 month post delivery |
| Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe renal impairment | As per treating physician evaluation of clinical assessments post-natal. | Up to 24 months post delivery |
| Number of participants whose fetal cystoscopy resulted in maternal complications | Maternal and obstetrical complications such as preterm premature rupture of the membranes (PPROM), prematurity (birth <37 weeks), extremely preterm birth (<32 weeks), and urological fistulae and fetal demise. | Day 1 post delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodrigo A Ruano, MD, PhD. | Contact | 305.243.0769 | rodrigo.ruano@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Ruano, MD, PhD. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D001748 | Urinary Bladder Neck Obstruction |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D020669 | Fetoscopes |
| ID | Term |
|---|---|
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
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| Fetal Cystoscopy | Procedure | A fetoscope will be inserted into the fetal bladder via the maternal abdomen and advanced into the fetal bladder outlet. Identified obstruction will be opened using laser. |
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| Mayo Clinic | Terminated | Rochester | Minnesota | 55905 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D052801 | Male Urogenital Diseases |