Back to resultsThe Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
Primary Purpose
Twin to Twin Transfusion Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Curved KARL STORZ fetoscope
Straight KARL STORZ fetoscope
Sponsored by
About this trial
This is an interventional treatment trial for Twin to Twin Transfusion Syndrome
Eligibility Criteria
Inclusion Criteria: pregnancy The patient fulfills the criteria for laser photocoagulation of placental anastomoses based on the standard of care fetal diagnosis of twin-to-twin transfusion syndrome Anterior placenta The patient provides signed informed consent that details the maternal and fetal risks involved with the procedure Exclusion Criteria: Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia Allergy or previous adverse reaction to a study medication specified in this protocol The patient does not fulfill the conventional criteria to undergo in-utero surgery, which is specific for each surgery Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy 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 Suspicion of a major recognized syndrome by ultrasound or MRI Maternal BMI >40 kg/m2 High risk for fetal hemophilia
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
KARL STORZ scopes
conventional scopes
Arm Description
Outcomes
Primary Outcome Measures
Operative time in minutes
Time from from operative cannula insertion until it is removed
Secondary Outcome Measures
Gestational age
Number of times additional fetoscopes are entered into the amniotic cavity to confirm completion of the in-utero intervention
Total number of procedures with completion of the laser ablation
Improved visualization as assessed by the Likert scale
This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree
Improved angle for laser visualization as assessed by the Likert scale
This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree
Total number of fetuses alive, after the laser photocoagulation procedure
Total number of maternal patients that present with morbidity
Total number of patients that have maternal and/or fetal perioperative complications
The number of participants that develop twin-anemia-polycythemia sequence (TAPS)
Number of live births
Number of neonates with a short-term morbidity
Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3)
Scored items on ASQ-3 address 5 areas of child development: communication, gross motor, Fine motor, problem solving, and personal-social and each of these have 6 questions each and is scored as yes( 10 points), sometimes (5 points) and not yet (0 points)-the total score is calculated for each area and scores should fall between 0-60, and a higher score indicates more development.
There is a 9 item overall developmental section that is answered categorically as yes or no answer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06084247
Brief Title
The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
Official Title
An Open Label Randomized-control Study on the Efficacy of the KARL STORZ Curved Fetoscope (11508aak) and Its Straight Version (11506aak) for Laser Photocoagulation of Placental Anastomoses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jimmy Espinoza
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for laser photocoagulation of placental anastomoses in patients with an anterior placenta and TTTS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin to Twin Transfusion Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KARL STORZ scopes
Arm Type
Experimental
Arm Title
conventional scopes
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Curved KARL STORZ fetoscope
Intervention Description
The KARLZ STORZ curved scope is used to see the inside of a pregnant person's uterus during minimally invasive surgery, similar to conventional scopes. The curved scope is rounded and thought to help visualize the anterior placenta because of its position on the uterus.
Intervention Type
Device
Intervention Name(s)
Straight KARL STORZ fetoscope
Intervention Description
The KARLZ STORZ straight scope is used to see the inside of a pregnant person's uterus during minimally invasive surgery
Primary Outcome Measure Information:
Title
Operative time in minutes
Description
Time from from operative cannula insertion until it is removed
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
Gestational age
Time Frame
at time of delivery (about 20 weeks from surgery)
Title
Number of times additional fetoscopes are entered into the amniotic cavity to confirm completion of the in-utero intervention
Time Frame
end of surgery (about 60 minutes after start of surgery)
Title
Total number of procedures with completion of the laser ablation
Time Frame
end of surgery (about 60 minutes after start of surgery)
Title
Improved visualization as assessed by the Likert scale
Description
This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree
Time Frame
end of surgery (about 60 minutes after start of surgery)
Title
Improved angle for laser visualization as assessed by the Likert scale
Description
This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree
Time Frame
end of surgery (about 60 minutes after start of surgery)
Title
Total number of fetuses alive, after the laser photocoagulation procedure
Time Frame
at discharge from hospital (about 24 hours after surgery)
Title
Total number of maternal patients that present with morbidity
Time Frame
at discharge from hospital (about 24 hours after surgery)
Title
Total number of patients that have maternal and/or fetal perioperative complications
Time Frame
end of surgery (about 60 minutes after start of surgery)
Title
The number of participants that develop twin-anemia-polycythemia sequence (TAPS)
Time Frame
end of surgery (about 60 minutes after start of surgery)
Title
Number of live births
Time Frame
at time of delivery (about 20 weeks from surgery)
Title
Number of neonates with a short-term morbidity
Time Frame
from birth until hospital discharge
Title
Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3)
Description
Scored items on ASQ-3 address 5 areas of child development: communication, gross motor, Fine motor, problem solving, and personal-social and each of these have 6 questions each and is scored as yes( 10 points), sometimes (5 points) and not yet (0 points)-the total score is calculated for each area and scores should fall between 0-60, and a higher score indicates more development.
There is a 9 item overall developmental section that is answered categorically as yes or no answer
Time Frame
24 months of age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnancy
The patient fulfills the criteria for laser photocoagulation of placental anastomoses based on the standard of care
fetal diagnosis of twin-to-twin transfusion syndrome
Anterior placenta
The patient provides signed informed consent that details the maternal and fetal risks involved with the procedure
Exclusion Criteria:
Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
Allergy or previous adverse reaction to a study medication specified in this protocol
The patient does not fulfill the conventional criteria to undergo in-utero surgery, which is specific for each surgery
Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy
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
Suspicion of a major recognized syndrome by ultrasound or MRI
Maternal BMI >40 kg/m2
High risk for fetal hemophilia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jimmy Espinoza, MD, MSc,FACOG
Phone
(713) 500-5859
Email
Jimmy.Espinoza@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elisa Garcia
Phone
713-500-6347
Email
Elisa.I.Garcia@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmy Espinoza, MD, MSc,FACOG
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimmy Espinoza, MD,MSc,FACOG
Phone
713-500-5859
Email
Jimmy.Espinoza@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Elisa Garcia
Phone
713-500-6347
Email
Elisa.I.Garcia@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
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