RECRUITING

A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures

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

In this research study, the investigators want to learn more about the role of new innovative surgical devices, the Karl Storz Curved and Straight Fetoscopes for in-utero surgery. A fetoscope is like a small telescope that can see inside of the uterus (womb) during minimally invasive surgery. The curved scope is used for patients with an anterior placenta (front of uterus), while the straight scope is used for patients with a posterior placenta (back of uterus). The scopes will be used to assist in procedures involving fetoscopic laser photocoagulation (FLP), which is a minimally invasive surgery that uses a small camera (fetoscope) to locate abnormal blood vessel connections in the placenta and seal them off using laser energy. These fetoscopes will be utilized in the diagnosis and management of various fetal conditions that can arise during pregnancy. Outcome data will be reported in a descriptive statistical analysis. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants in order to evaluate the benefit of using these devices.

Official Title

A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures

Quick Facts

Study Start:2024-08-15
Study Completion:2027-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06056635

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 patient with a condition requiring in-utero surgery
  2. * Patient must be eligible for anesthesia
  3. * Patient and father of the fetus (if available) are able to provide signed informed consent
  1. * Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative
  2. * Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy
  3. * Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
  4. * Pre-pregnancy maternal BMI greater than 40
  5. * High risk for fetal hemophilia
  6. * Fetal aneuploidy or variants of known significance if an amniocentesis was performed
  7. * Contraindication to abdominal surgery or fetoscopic surgery

Contacts and Locations

Study Contact

Brittany Gudanowski
CONTACT
617-919-6658
Brittany.Gudanowski@childrens.harvard.edu

Principal Investigator

Eyal Krispin, MD
PRINCIPAL_INVESTIGATOR
Fetal Surgeon

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Eyal Krispin, MD, PRINCIPAL_INVESTIGATOR, Fetal Surgeon

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 Date2024-08-15
Study Completion Date2027-05-01

Study Record Updates

Study Start Date2024-08-15
Study Completion Date2027-05-01

Terms related to this study

Keywords Provided by Researchers

  • Fetoscope
  • Fetoscopic Laser Ablation
  • Diagnostic Fetoscopy

Additional Relevant MeSH Terms

  • Fetal Conditions
  • Maternal; Procedure
  • Pregnancy Related
  • Twin to Twin Transfusion Syndrome
  • In Utero Procedure Affecting Fetus or Newborn
  • Chorion; Abnormal
  • Twin Reversal Arterial Perfusion Syndrome
  • Twin Monochorionic Monoamniotic Placenta
  • Chorioangioma
  • Vasa Previa