Clinical trial NCT02506049: Laser Photocoagulation in Twin to Twin Transfusion Syndrome
Official title: Fetoscopic Directed Laser Photocoagulation of Communicating Placental Vessels in Twin to Twin Transfusion Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Twin to Twin Transfusion Syndrome
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Regional Medical Center, Regional One Health
First posted: 2015-07-22
Enrollment: 1
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Humanitarian use device (HUD): Use of the fetoscopy instrument sets for selective laser photocoagulation in the treatment of Twin to Twin Transfusion Syndrome (TTTS).

Detailed description: Patients initially will be identified by ultrasound examination by their primary provider. Consultation and subsequent ultrasound confirmation will be undertaken by our group. Patients meeting the inclusion criteria will undergo extensive verbal counseling regarding the clinical findings, prognosis, and management options. Those electing to proceed will sign written informed consent documents.

More specifically, after initial referral to our center for TTTS management, patients will undergo targeted ultrasound to confirm the diagnosis. If confirmed, patients will undergo extensive counseling regarding various management options. Those patients electing to proceed with selective laser photocoagulation (S-LPC) will undergo the informed consent process. The S-LPC will be performed in the Labor and Delivery (L\&D), Operating Room (OR) at the Regional Medical Center, Regional One Health (RMC,ROH). In the majority of cases, maternal anesthesia will be an epidural. In those cases where the patient is unable to lay supine due to an enlarged uterus (resulting in maternal hypotension or respiratory insufficiency, or maternal anxiety), general anesthesia with intubation will be administered. In rare cases, intravenous sedation with infiltration of a local anesthetic into the skin, deep muscle, and fascia will be used. Following the administration of maternal anesthesia, ultrasound will be performed to assess fetal position, placentation, and select a site for insertion of the operative instruments. A small skin incision will be made following administration of local anesthetic to allow percutaneous access to the recipient gestational sac. An 18 gauge needle will be inserted through the maternal abdomen and uterus into the gestational sac. Once secured in place, the stylet will be removed and a J guide wire will be inserted through the needle. The needle will be removed and a 10-12 Fr (3-3.4 mm) trocar and cannula will be inserted into the sac over the guide wire. The trocar and guide wire will be removed and the fetoscopy instruments will be introduced through the cannula. The procedure is performed under continuous ultrasound guidance. After introduction of the fetoscope and operating sheath, the placenta is inspected by direct visualization for communicating vessels between the recipient and donor twin. A 400-600 micron laser fiber is introduced into the gestational sac via an instrument channel in the operating sheath. The fiber is directed to the communicating vessels, which are then ablated with thermal energy. An average of 7-15 sites will be ablated. At the completion of the procedure the amniotic fluid volume in the recipient sac will be reduced to a normal volume. Follow-up visits to track maternal and fetal progress after the procedure will be scheduled with our group.

Eligibility criteria: Inclusion Criteria:

* The device will be used in multifetal pregnancies affected with twin-to-twin transfusion syndrome (TTTS) at less than 27 weeks of gestation

Exclusion Criteria:

* All other pregnancies not meeting inclusion criteria

Primary outcomes:
measure: Laser ablation of placental anastomoses for treatment of severe TTTS and establishment of normalized blood flow between the fetal twins.
timeFrame: The device will be used in multifetal pregnancies affected with twin-to-twin transfusion syndrome (TTTS) at less than 27 weeks of gestation;procedure will last approx 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Regional One Health, Regional Medical Center, Rout Center for Women and Children
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Science Center, OB-GYN
state: Tennessee
Study officials:
affiliation: Prof. & Chair, UTHSC; Dir.,TN Inst. of Feto-Maternal & Infant Health; Dir., High-Risk Obstetrics Ctr of Excell., Regional Medical Ctr
name: Giancarlo Mari, M.D., MBA
role: PRINCIPAL_INVESTIGATOR
References: