The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses

Study Overview
=================
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 Twin to Twin Transfusion Syndrome (TTTS).

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

Conditions
-----------------
Twin to Twin Transfusion Syndrome

Intervention / Treatment
-----------------
* Device: Curved KARL STORZ fetoscope
* Device: Conventional Scopes


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KARL STORZ Curved Scope<br> | Device: Curved KARL STORZ fetoscope<br>* 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.<br>|
| Active Comparator: Conventional scopes<br> | Device: Conventional Scopes<br>* The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time in minutes | Time from from operative cannula insertion until it is removed | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants that have a gestational age of less than 37 weeks |  | at time of delivery (about 20 weeks from surgery) | 
| Number of times additional fetoscopes are entered into the amniotic cavity to confirm completion of the in-utero intervention |  | end of surgery (about 60 minutes after start of surgery) | 
| Total number of procedures with completion of the laser ablation |  | end of surgery (about 60 minutes after start of surgery) | 
| Improved visualization as assessed by the Likert scale | This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree. This is not a validated scale and does not have an official title. The minimum value is strongly disagree and the maximum value is strongly agree. Higher scores mean better outcomes. | end of surgery (about 60 minutes after start of surgery) | 
| 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 | end of surgery (about 60 minutes after start of surgery) | 
| Total number of fetuses alive, after the laser photocoagulation procedure |  | at discharge from hospital (about 24 hours after surgery) | 
| Total number of maternal patients that present with morbidity |  | at discharge from hospital (about 24 hours after surgery) | 
| Total number of patients that have maternal and/or fetal perioperative complications |  | end of surgery (about 60 minutes after start of surgery) | 
| The number of participants that develop twin-anemia-polycythemia sequence (TAPS) |  | end of surgery (about 60 minutes after start of surgery) | 
| Number of live births |  | at time of delivery (about 20 weeks from surgery) | 
| Number of neonates with a short-term morbidity |  | from birth until hospital discharge | 
| 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 | 24 months of age |