Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KARL STORZ Curved Scope | Experimental |
| |
| Conventional scopes | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curved KARL STORZ fetoscope | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time in minutes | Time from from operative cannula insertion until it is removed | during surgery |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Jimmy Espinoza, MD, MSc,FACOG | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional Scopes | Device | The conventional scopes are regularly used during laser photocoagulation of placental anastomoses. |
|
| 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 |
| ID | Term |
|---|---|
| D005330 | Fetofetal Transfusion |
| ID | Term |
|---|---|
| D000751 | Anemia, Neonatal |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided