Enrolling by invitation NCT07572227
Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fetal cystoscope.
- Who it may be relevant to
- Registry conditions: Lower Urinary Tract Obstruction, Congenital. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this research is to determine the feasibility and safety of performing fetal operative cystoscopy for the treatment of Lower Urinary Tract Obstruction (LUTO) using investigational devices.
Detailed description
Fetal cystoscopy involves the use of a tiny camera to find the cause of the urinary tract blockage and to treat it at the same time. When a fetus is found to have LUTO, this means there is a blockage in the urethra (tube that passes urine from the bladder to outside the body) which leads to kidney, lung, and other organ damage in the fetus.
Fetal surgery is when the unborn baby is in the mother's uterus (in utero). This study will see if certain investigational devices are safe for the fetal cystoscopy procedure.
Interventions
- Device Fetal cystoscope
The fetoscope assembly includes the the Boston Scientific Maverick 2 balloon catheter and Emerge balloon, the Karl Storz Miniature Straight Forward Telescope, Operating Sheath, and connector. A fetal cystoscopy will be performed for treatment of lower urinary tract obstruction complicated by oligo/anhydramnios.
Primary outcome measures
- Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra [Time frame: 24 months]
- Number of procedures that achieved technical success of posterior urethral valve ablation with laser to allow passage of balloon [Time frame: 24 months]
- Number of procedures that achieved technical success of valvuloplasty [Time frame: 24 months]
Secondary outcome measures (12)
- Amniotic fluid volume after the procedure (major vertical pocket) [Time frame: 24 hours after procedure]
- Fetal lung growth after treatment [Time frame: Baseline]
- Number of fetuses to experience complications [Time frame: Baseline]
- Number of mothers to experience complications [Time frame: Baseline]
- Gestational age at delivery [Time frame: Gestational age at delivery, up to 9 months]
- Renal changes after treatment [Time frame: 24 months]
- Survival rate [Time frame: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age]
- Serum creatinine level [Time frame: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age]
- Need for dialysis [Time frame: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age]
- Grading of oxygen dependency [Time frame: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age]
- Occurrence of severe pulmonary hypertension [Time frame: Baseline]
- Use of extracorporeal membrane oxygenation (ECMO) support during post-natal follow-up [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
- Pregnant women carrying a singleton gestation and male fetus
- Able to perform the procedure at a gestational age between 16 0/7 and 25 6/7 weeks of gestation
- Lower urinary tract obstruction: Enlarged bladder (subjectively assessed), keyhole sign, bladder wall thickening (subjectively assessed), and bilateral hydro (uretero) nephrosis.27
- Absence of chromosomal abnormalities and other anomalies unrelated to the urinary tract obstruction.
- Oligo or anhydramnios at or after 16 weeks of gestation
- Evidence of conserved renal function (a Nassr et al., score of 3 or less ).
- Able to understand the requirements of the study, and willing and able to consent for enrollment in the study
Exclusion criteria
- Severe maternal health condition precluding procedure.
- Increased risk for preterm labor including short cervical length, history of incompetent cervix with or without cerclage, and previous preterm birth
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
- Contraindications to surgery including previous hysterotomy in active uterine segment (at or above the level of the round ligaments).
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery o
- Female fetus
- Significant pathogenic or likely pathogenic finding on karyotype or microarray
- Significant unrelated fetal anomaly, as opposed to a nonsignificant one that would not preclude enrollment.
- Multiple gestation
- Technical limitations precluding the procedure, such as, no fetoscopic approach due to placental position or fetal position.
- Inability to comply with travel and follow-up requirements of the trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07572227 · 23-008546