Trial Outcomes & Findings for Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia (NCT NCT03059030)

Last Updated: 2025-02-03

Results Overview

The number and the severity of ALL adverse events will be recorded to evaluate safety. Events will be reported by subjects at follow up visits. Scale: Common Terminology Criteria for Adverse Events (CTCAE) CT CAE v 4.0.3 Grades range from 1-5 with 5 being the worst (Death), descriptions of each grade for specific AE's are available here: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE\_4.03/CTCAE\_4.03\_2010-06-14\_QuickReference\_8.5x11.pdf Total AE's of different types are collected and for each grade are reported as a group

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

6 months

Results posted on

2025-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia. TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.: The Interventional Radiologists will inject a dose of Yttrium 90 into your spleen through a small catheter placed in your femoral artery.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n=7 Participants Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia. TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.: The Interventional Radiologists will inject a dose of Yttrium 90 into your spleen through a small catheter placed in your femoral artery.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age, Continuous	61 years n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	7 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All subjects enrolled received treatment per protocol.

Outcome measures

Outcome measures
Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n=7 Participants There is only one arm of the study where patients received treatment.
The Primary Objective of This Pilot Study is to Evaluate the Safety of 90Y TARE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Evaluation of Overall AE Reporting in All Categories. Grade 1 AE	49 events
The Primary Objective of This Pilot Study is to Evaluate the Safety of 90Y TARE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Evaluation of Overall AE Reporting in All Categories. Grade 2 AE	34 events
The Primary Objective of This Pilot Study is to Evaluate the Safety of 90Y TARE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Evaluation of Overall AE Reporting in All Categories. Grade 3 AE	28 events
The Primary Objective of This Pilot Study is to Evaluate the Safety of 90Y TARE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Evaluation of Overall AE Reporting in All Categories. Grade 4 AE	15 events
The Primary Objective of This Pilot Study is to Evaluate the Safety of 90Y TARE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Evaluation of Overall AE Reporting in All Categories. Grade 5 AE	0 events

PRIMARY outcome

Timeframe: 6 months

Population: All subjects treated on study.

The number and the severity of adverse events related to splenic abscess will be recorded to evaluate safety. Events will be reported by subjects at follow up visits. Scale: Common Terminology Criteria for Adverse Events (CTCAE) CT CAE v 4.0.3 Grades range from 1-5 with 5 being the worst (Death), Grade 1 (Mild):Small abscess with minimal symptoms, often not requiring intervention. Grade 2 (Moderate):Larger abscess causing moderate symptoms, may require antibiotics or drainage procedures. Grade 3 (Severe):Large abscess with significant symptoms, potentially causing systemic effects, requiring hospitalization and aggressive management. Grade 4 (Life-threatening):Abscess with immediate life-threatening complications, requiring urgent intervention. Grade 5 Death

Outcome measures

Outcome measures
Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n=7 Participants There is only one arm of the study where patients received treatment.
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess. Grade 1	0 events
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess. Grade 2	0 events
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess. Grade 3	0 events
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess. Grade 4	0 events
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess. Grade 5	0 events

PRIMARY outcome

Timeframe: 6 months

Population: 3 subjects reported infections these were unrelated to treatment on study. Pneumonia grade 3, lung infection grade 3, vaginal infection grade 2. All resolved before the study was completed.

The number and the severity of adverse events related to infection will be recorded to evaluate safety. Events will be reported by subjects at follow up visits. Common Terminology Criteria for Adverse Events (CTCAE) CT CAE v 4.0.3, Grades range from 1-5 with 5 being the worst (Death) Grade 1 (Mild): Asymptomatic or mild symptoms, only requiring clinical observation, no intervention needed. Grade 2 (Moderate): Symptoms limiting some daily activities, minimal intervention may be required. Grade 3 (Severe): Symptoms significantly impacting self-care, requiring hospitalization or prolonged stay. Grade 4 (Life-threatening): Urgent intervention needed due to life-threatening complications. Grade 5 (Death): Death directly related to the infection.

Outcome measures

Outcome measures
Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n=7 Participants There is only one arm of the study where patients received treatment.
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection. Grade 1	0 events
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection. Grade 2	1 events
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection. Grade 3	2 events
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection. Grade 4	0 events
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection. Grade 5	0 events

PRIMARY outcome

Timeframe: 6 months

Population: All four patients that received Tc-MAA to determine shunting prior to Y90 RE had a lung shunt fraction \<5%. Given this finding no subsequent patients needed MAA or lung shunt study performed.

MAA injection will be done and nuclear medicine PET scan to evaluate shunting and evaluated for the first 4 patients. If shunt is \<5% subsequently enrolled patients will not undergo MAA, if shunt is \>5% all subsequent patients will undergo MAA. This will be evaluated post MAA injection before Y90 treatment.

Outcome measures

Outcome measures
Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n=4 Participants There is only one arm of the study where patients received treatment.
Asses the Need for Technetium Albumin Aggregated (TC-MAA 99m) Injection to Determine Shunting Prior to Y90 Administration	0 participants

SECONDARY outcome

Timeframe: 6 months

Population: The 7 participating subjects had platelets drawn 6 months post procedure.

Complete Blood Count with platelets will be drawn at baseline, treatment, 2, 4, 6, 8 weeks and 3, 4, 5, 6 months post treatment. Comparison made with screening platelet count and 6 month follow up visit platelet count.

Outcome measures

Outcome measures
Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n=7 Participants There is only one arm of the study where patients received treatment.
Achieve a 50% Increase in Platelet Count Six Months After Therapy. Achieved 50% increase in 6 months	0 participants
Achieve a 50% Increase in Platelet Count Six Months After Therapy. Did not achieve 50% increase in 6 months	7 participants

SECONDARY outcome

Timeframe: 6 months

Population: All subjects had a CT or MR at screening, 1 month, 3 months, and 6moths timepoints. Splenic volumes were reported at all time points.

Assessed via cross sectional CT or MR of the abdomen at screening and at 4 weeks, 3 months, and 6 months post treatment. Comparison made with screening CT or MR and 6 month follow up imaging.

Outcome measures

Outcome measures
Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n=7 Participants There is only one arm of the study where patients received treatment.
Achieve 20% Decrease in Functional Splenic Volume Six Months After Treatment Achieved 20% decrease in volume	1 participants
Achieve 20% Decrease in Functional Splenic Volume Six Months After Treatment Did not achieve 20% decrease in volume	6 participants

SECONDARY outcome

Timeframe: 6 months

Population: no subjects were admitted after their procedure so there are 0 days hospitalized to report or analyze.

Determine the average length of stay in the hospital in days after treatment.

Outcome measures

Outcome data not reported

Adverse Events

Subjects With Thrombocytopenia Secondary to Cirrhosis

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n=7 participants at risk Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia. TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.: The Interventional Radiologists will inject a dose of Yttrium 90 into your spleen through a small catheter placed in your femoral artery. There was only one arm of this study and all subjects were treated. No subjects had severe adverse events and none died during the duration of the study. All adverse events reported at follow up visits were reported.
Blood and lymphatic system disorders White Blood Cell Count Decreased	85.7% 6/7 • Number of events 7 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Blood and lymphatic system disorders Lymphocyte Count Decreased	100.0% 7/7 • Number of events 7 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Blood and lymphatic system disorders Anemia	71.4% 5/7 • Number of events 6 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Blood and lymphatic system disorders Neutrophil count decreased	71.4% 5/7 • Number of events 5 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Hepatobiliary disorders Alkaline Phosphatase Increased	28.6% 2/7 • Number of events 2 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Hepatobiliary disorders Ascites	42.9% 3/7 • Number of events 3 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Fatigue	71.4% 5/7 • Number of events 6 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Anorexia	28.6% 2/7 • Number of events 2 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Nausea	42.9% 3/7 • Number of events 3 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Presyncope	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Cardiac disorders Chest Pain	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Respiratory, thoracic and mediastinal disorders Dyspnea	42.9% 3/7 • Number of events 3 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Constipation	28.6% 2/7 • Number of events 2 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Pain in extremity	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Blood and lymphatic system disorders Limb Edema	28.6% 2/7 • Number of events 2 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Upper GI Hemorrhage	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Renal and urinary disorders Acute Kidney injury	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Endocrine disorders Hyperkalemia	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Endocrine disorders Hypokalemia	28.6% 2/7 • Number of events 3 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Endocrine disorders Hypocalcemia	42.9% 3/7 • Number of events 4 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Hepatobiliary disorders Hypoalbuminemia	57.1% 4/7 • Number of events 4 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Endocrine disorders Hyponatremia	57.1% 4/7 • Number of events 4 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Skin and subcutaneous tissue disorders Dry Skin	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Bloating	28.6% 2/7 • Number of events 2 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Reproductive system and breast disorders Vaginal Infection	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Lower GI Hemorrhage	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Musculoskeletal and connective tissue disorders Knee Pain	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Blood and lymphatic system disorders Cholesterol High	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Dyspepsia	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Abdominal Pain	42.9% 3/7 • Number of events 5 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Hiccupping	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Blood and lymphatic system disorders Decreased Platelet Count	42.9% 3/7 • Number of events 3 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Cardiac disorders Increased Cardiac Troponin I	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Musculoskeletal and connective tissue disorders Back Pain	42.9% 3/7 • Number of events 3 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Bruising	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Cardiac disorders Right Ventricular Dysfunction	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Hot Flashes	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Renal and urinary disorders Chronic Kidney Disease	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Hernia Pain	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Blood and lymphatic system disorders Genital Edema	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Reproductive system and breast disorders Scrotal Pain	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Wound Dehiscence	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Small Intestinal Obstruction	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Respiratory, thoracic and mediastinal disorders Lung Infection	28.6% 2/7 • Number of events 2 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm -Antral polyp	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Blood and lymphatic system disorders Edema Face	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Hepatobiliary disorders Blood Bilirubin increased	28.6% 2/7 • Number of events 2 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Chills	28.6% 2/7 • Number of events 2 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Blood and lymphatic system disorders INR Increased	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Cardiac disorders Hypertension	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Cardiac disorders Hypotension	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Insomnia	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Pelvic Pain	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Weight Loss	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Worsening GI Reflux	14.3% 1/7 • Number of events 2 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Blood and lymphatic system disorders Aspartate Aminotransferase Increased	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Dizziness	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Renal and urinary disorders Increased Creatnine	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Gastrointestinal disorders Diarrhea	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
General disorders Fever	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Skin and subcutaneous tissue disorders Skin disorder Atypical nevi abdomen	14.3% 1/7 • Number of events 1 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.
Endocrine disorders Hyperglycemia	14.3% 1/7 • Number of events 2 • 6 months Adverse events were collected at all follow up visits: 2 weeks, 1 month, 6 weeks, 2, 3, 4, 5, and 6 months post procedure.

Additional Information

Riad Salem MD

Northwestern University

Phone: 312-695-6371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place