RECRUITING

The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

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Conditions

In Utero Procedure Affecting Fetus or Newborn

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery

Official Title

A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

Quick Facts

Study Start:2024-04-04
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06425471

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant woman
  2. * The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition
  3. * Patient of the baby provides signed informed consent that details the maternal and fetal risks involved with the procedure
  1. * Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
  2. * Allergy or previous adverse reaction to a study medication specified in this protocol
  3. * Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy
  4. * Fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation
  5. * Suspicion of a major recognized syndrome by ultrasound or MRI
  6. * Maternal BMI \>40 kg/m2
  7. * High risk for fetal hemophilia

Contacts and Locations

Study Contact

Jimmy Espinoza, MD, MSc,FACOG
CONTACT
(713) 500-5859
Jimmy.Espinoza@uth.tmc.edu
Elisa Garcia
CONTACT
713-500-6347
Elisa.I.Garcia@uth.tmc.edu

Principal Investigator

Jimmy Espinoza, MD, MSc,FACOG
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Jimmy Espinoza, MD, MSc,FACOG, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-04-04
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • In Utero Procedure Affecting Fetus or Newborn