---
title: The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
nct_id: NCT06084247
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: Jimmy Espinoza
study_type: INTERVENTIONAL
primary_condition: Twin to Twin Transfusion Syndrome
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06084247.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06084247"
ct_last_update_post_date: 2025-08-14
last_seen_at: "2026-05-12T06:43:24.561Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT06084247](https://clinicaltrials.gov/study/NCT06084247)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 160
- **Lead Sponsor:** Jimmy Espinoza
- **Conditions:** Twin to Twin Transfusion Syndrome
- **Start Date:** 2025-09-01
- **Completion Date:** 2027-12-01
- **CT.gov Last Update:** 2025-08-14

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **KARL STORZ Curved Scope** (EXPERIMENTAL)
- **Conventional scopes** (ACTIVE_COMPARATOR)

## Interventions

- **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.
- **Conventional Scopes** (DEVICE) — The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.

## Primary Outcomes

- **Operative time in minutes** _(time frame: during surgery)_ — Time from from operative cannula insertion until it is removed

## Secondary Outcomes

- **Number of Participants that have a gestational age of less than 37 weeks** _(time frame: 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** _(time frame: end of surgery (about 60 minutes after start of surgery))_
- **Total number of procedures with completion of the laser ablation** _(time frame: end of surgery (about 60 minutes after start of surgery))_
- **Improved visualization as assessed by the Likert scale** _(time frame: end of surgery (about 60 minutes after start of surgery))_
- **Improved angle for laser visualization as assessed by the Likert scale** _(time frame: end of surgery (about 60 minutes after start of surgery))_
- **Total number of fetuses alive, after the laser photocoagulation procedure** _(time frame: at discharge from hospital (about 24 hours after surgery))_
- **Total number of maternal patients that present with morbidity** _(time frame: at discharge from hospital (about 24 hours after surgery))_
- **Total number of patients that have maternal and/or fetal perioperative complications** _(time frame: end of surgery (about 60 minutes after start of surgery))_
- **The number of participants that develop twin-anemia-polycythemia sequence (TAPS)** _(time frame: end of surgery (about 60 minutes after start of surgery))_
- **Number of live births** _(time frame: at time of delivery (about 20 weeks from surgery))_
- **Number of neonates with a short-term morbidity** _(time frame: from birth until hospital discharge)_
- **Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3)** _(time frame: 24 months of age)_

## Locations (1)

- The University of Texas Health Science Center at Houston, Houston, Texas, United States

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the university of texas health science center at houston|houston|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06084247.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06084247*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*