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COMPLETED NA

Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery

NCT01220011 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. This trial will answer an important question and will help in the management and tailoring of surgical indications in stage 1 TTTS.

Interventions

  • PROCEDURE Fetoscopic laser surgery

Study Locations (11)

Ohio

  • Fetal Care Center of Cincinnati, Cincinnati Children's Hospital Medical Center — Cincinnati
  • The Ohio State University / OSU Fetal Therapy Program — Columbus

Colorado

  • Children's Hospital Colorado and Colorado Fetal Care Center — Aurora

Maryland

  • University of MD /Department of Obstetrics, Gynecology & Reproductive Sciences — Baltimore

Pennsylvania

  • Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia — Philadelphia

Rhode Island

  • Fetal Treatment Program of New England, Hasbro Children's Hospital, The Warren Alpert Medical School of Brown University. — Providence

Texas

  • The Texas Fetal Center, Children's Memorial Hermann Hospital, University of Texas Medical School — Houston

Washington

  • Fetal Therapy Program, Evergrenn Hospital Medical Center — Kirkland

Ontario

  • Mount Sinai Hospital, University of Toronto — Toronto

Trial Details

FieldValue
Enrollment Target 179 participants
Start Date 2011-04-19
Est. Completion 2019-03-31
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01220011

The ClinicalTrials.gov registry entry for NCT01220011 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Assistance Publique - Hôpitaux de Paris, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Infant, Newborn, Diseases appearing as the primary indexed condition, and to 1 intervention — of which Fetoscopic laser surgery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01220011 reports 11 study locations spanning 10 distinct geographic areas — top geographies include Ohio, Colorado, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01220011 about?

NCT01220011 is a clinical study titled "Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery". The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. This trial will answer an important question and will help in the management and ta...

What is the current status of trial NCT01220011?

This trial is currently completed. It is a NA study. The enrollment target is 179 participants. The study started on 2011-04-19. Estimated completion is 2019-03-31.

What conditions does trial NCT01220011 study?

This clinical trial studies the following conditions: Infant, Newborn, Diseases, Hematologic Disease, Blood and Blood Disorders, Anemia, Neonatal. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01220011?

The interventions under investigation include: Fetoscopic laser surgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01220011?

This trial is sponsored by Assistance Publique - Hôpitaux de Paris, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01220011 being conducted?

This trial has 11 study locations across Colorado, Maryland, Ohio, Pennsylvania, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial