## Protocol Section
### Identification Module
**NCT ID:** NCT06425471

**Brief Title:** A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

**Official Title:** A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

#### Organization Study ID Info
**ID:** HSC-MS-22-1019
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center, Houston
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-04

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Texas Health Science Center, Houston

#### Responsible Party

**Investigator Affiliation:** The University of Texas Health Science Center, Houston

**Investigator Full Name:** Jimmy Espinoza

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery

**Detailed Description:** Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes

### Conditions Module

**Conditions:**

- In Utero Procedure Affecting Fetus or Newborn

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: KARL STORZ fetoscope arm

**Label:** KARL STORZ fetoscope arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- KARL STORZ fetoscope arm

**Description:** The type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS)

**Name:** KARL STORZ fetoscope arm

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Gestational age at delivery in patients requiring percutaneous in-utero surgery

**Time Frame:** at time of delivery (about 10 weeks after in utero surgery)

#### Secondary Outcomes

**Measure:** Number of successful procedures with completion of laser ablation of the abnormal vessels.

**Time Frame:** within 24 hours of in utero surgery

**Description:** 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.

**Measure:** Improved visualization as assessed by the Likert scale

**Time Frame:** within 24 hours of in utero surgery

**Description:** This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree

**Measure:** Improved angle for laser visualization as assessed by the Likert scale

**Time Frame:** within 24 hours of in utero surgery

**Description:** This is a 4 item questionnaire and each is scored from 1(poor) to 5(excellent) for a maximum score of 20 higher score indicating better outcome

**Measure:** Improved ease of use of the new fetoscope as assessed by a questionnaire

**Time Frame:** within 24 hours of in utero surgery

**Description:** Time from from operative cannula insertion until it is removed

**Measure:** Operative time in minutes

**Time Frame:** end of surgery ( about 1 hour form start of surgery)

**Measure:** Number of fetuses alive prior to hospital discharge

**Time Frame:** time of discharge (about 48 hours after surgery)

**Description:** Short term morbidity includes but is not limited to, preterm labor, preterm premature rupture of membranes, or placental abruption

**Measure:** Total number of maternal patients that present with short term morbidity

**Time Frame:** from end of surgery to within 10 weeks after surgery

**Measure:** Total number of patients that have maternal and/or fetal perioperative complications

**Time Frame:** from end of surgery to within 10 weeks after surgery

**Measure:** The number of participants that develop twin-anemia-polycythemia sequence (TAPS)

**Time Frame:** from end of surgery to within 10 weeks after surgery

**Measure:** Total number of live births

**Time Frame:** from time of in utero surgery till delivery (about 10 weeks after surgery)

**Description:** Short-term morbidities include, but are not limited to, premature delivery (\<37 weeks), the need for extracorporeal membrane oxygenation (ECMO), neurological abnormalities found by MRI or ultrasound, gastrointestinal problems, oxygen support, infection and other problems associated with prematurity, including but not limited to, necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, and neonatal sepsis.

**Measure:** Total number of short-term morbidities

**Time Frame:** from time of in utero surgery till delivery (about 10 weeks after surgery)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Pregnant woman
* The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition
* Patient of the baby 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
* 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

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Jimmy.Espinoza@uth.tmc.edu

**Name:** Jimmy Espinoza, MD, MSc,FACOG

**Phone:** (713) 500-5859

**Role:** CONTACT

**Contact 2:**

**Email:** Elisa.I.Garcia@uth.tmc.edu

**Name:** Elisa Garcia

**Phone:** 713-500-6347

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** Jimmy.Espinoza@uth.tmc.edu

- **Name:** Jimmy Espinoza, MD, MSc,FACOG

- **Phone:** (713) 500-5859

- **Role:** CONTACT

***Contact 2:***

- **Email:** Elisa.I.Garcia@uth.tmc.edu

- **Name:** Elisa Garcia

- **Phone:** 713-500-6347

- **Role:** CONTACT

**Country:** United States

**Facility:** The University of Texas health Science Center at Houston

**State:** Texas

**Status:** RECRUITING

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** The University of Texas Health Science Center, Houston

**Name:** Jimmy Espinoza, MD, MSc,FACOG

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
