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

ConditionTwin to Twin Transfusion Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorJimmy Espinoza

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: KARL STORZ Curved ScopeExperimental treatment 1 intervention
Group B: Conventional scopesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Operative time in minutes

Time from from operative cannula insertion until it is removed

Time frame
during surgery

Secondary outcomes

1

Number of Participants that have a gestational age of less than 37 weeks

Time frame
at time of delivery (about 20 weeks from surgery)
2

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)
3

Total number of procedures with completion of the laser ablation

Time frame
end of surgery (about 60 minutes after start of surgery)
4

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.

Time frame
end of surgery (about 60 minutes after start of surgery)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jimmy Espinoza

Lead sponsor

The University of Texas Health Science Center, Houston

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: