Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO) (LUTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281798
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Rodrigo Ruano M.D., Ph.D, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 11, 2017
First Posted Date  ICMJE September 13, 2017
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
Number of successfully completed surgical procedures [ Time Frame: Four hours following start of surgical procedure ]
Performance of percutaneous fetal cystoscopy with ultrasound-fetoscopic guidance
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO)
Official Title  ICMJE Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial
Brief Summary

This is a pilot study to evaluate the safety, feasibility and effectiveness of fetal cystoscopy in the prenatal diagnosis and therapy of fetuses with bladder outlet obstruction. Fetal bladder outlet obstruction is a rare congenital anomaly with severe consequences to the fetus. Because of the bladder outlet obstruction, amniotic fluid is diminished, drastically leading to abnormal development of the fetal lungs. In addition, the obstruction leads to significant kidney damage, including development of end stage renal disease. Fetal vesicoamniotic shunting is the clinical therapeutic option for these fetuses. However, the shunt has many complications including blockage and dislodgement. Fetal cystoscopy has been proposed as an alternative treatment with potential advantages over the shunt by allowing the correct prenatal diagnosis and specific treatment. Initial clinical trials have demonstrated favorable outcomes.

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) at Mayo Clinic in Rochester, Minnesota. The objectives are to evaluate the safety, feasibility, and effectiveness of fetal cystoscopy as an experimental procedure in avoiding perinatal death and renal impairment and to compare to our clinical experience with fetal vesico-amniotic shunting.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Congenital Disorders
  • Bilateral Hydronephrosis
  • Lower Urinary Tract Obstructive Syndrome
Intervention  ICMJE Device: Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set
2.0 mm fetoscopy or flexible ureteroscope
Study Arms  ICMJE Experimental: Fetuses with LUTO
Performance of ultrasound-guided, percutaneous fetal cystoscopy with the Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set
Intervention: Device: Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant females age ≥ 18 years
  • Oligohydramnios or Anhydramnios
  • Singleton male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
  • Urine analysis: urinary sodium < 100 milliequivalents per liter (mEq/L), chloride < 90 mEq/L, osmolarity <200 milliosmoles/liter (mOsm/L) and β2-microglobulin <6mg/L
  • Absence of chromosomal abnormalities and associated anomalies
  • Gestational age at the time of the procedure between 16 0/7 weeks and 25 6/7 weeks
  • Normal karyotype by invasive testing (amniocentesis or CVS).
  • Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.
  • Family has sufficient social support and ability to understand requirements of the study.
  • Parents or guardians are willing to provide signed informed consent.

Exclusion Criteria:

  • Fetal anomaly or congenital cardiac anomaly unrelated to LUTO
  • Female fetus
  • Increased risk for preterm labor, cervical length (<1.5 cm), previous preterm birth, history of incompetent cervix with or without cerclage
  • Placental abnormalities (previa, abruption, accreta) known at time of enrollment
  • Contraindications to surgery including previous hysterotomy in active uterine segment
  • Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
  • Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
  • Maternal HIV, Hepatitis-B, Hepatitis-C positive (testing must be done and be negative)
  • Maternal medical condition that is a contraindication to surgery or anesthesia
  • Patient does not have health insurance to cover routine prenatal clinical care, including prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting
  • Inability to comply with travel and follow-up requirements of the trial
  • Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
  • Patients declining invasive testing
  • Unable to understand the study procedures or unable to provide voluntary informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Females of child-bearing age
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shonie L Buenvenida, BSN, RN 507-255-8752 buenvenida.shonie@mayo.edu
Contact: Maureen A Lemens, BSN, RN 507-293-1487 lemens.maureen@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03281798
Other Study ID Numbers  ICMJE 16-008556
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rodrigo Ruano M.D., Ph.D, Mayo Clinic
Study Sponsor  ICMJE Rodrigo Ruano M.D., Ph.D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodrigo Ruano, M.D., Ph.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP