Trial Outcomes & Findings for Irreversible Electroporation Ablation for Colorectal Metastases to the Lung (NCT NCT02461550)

Last Updated: 2018-01-08

Results Overview

Safety will be measured by using the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0). The goal of this study is to establish safety. If there are 3 or more grade 3 or higher device related AEs, then we will stop the study.

Recruitment status

COMPLETED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

2 years

Results posted on

2018-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	IRE Procedure The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist. Irreversible Electroporation Ablation
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IRE Procedure n=2 Participants The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist. Irreversible Electroporation Ablation
Age, Continuous	42 years n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 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	0 Participants n=99 Participants
Race (NIH/OMB) White	2 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	2 Participants n=99 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

IRE Procedure

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IRE Procedure n=2 participants at risk The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist. Irreversible Electroporation Ablation
Respiratory, thoracic and mediastinal disorders Pneumothorax	100.0% 2/2 • 6 months
Blood and lymphatic system disorders Anemia	50.0% 1/2 • 6 months
General disorders Fever	50.0% 1/2 • 6 months
Metabolism and nutrition disorders Hypocalcemia	50.0% 1/2 • 6 months
Metabolism and nutrition disorders Hypophosphatemia	50.0% 1/2 • 6 months
Investigations Lymphocyte count decreased	50.0% 1/2 • 6 months
Respiratory, thoracic and mediastinal disorders Productive cough	50.0% 1/2 • 6 months
Respiratory, thoracic and mediastinal disorders Resp, thoracic & mediastinal disorder	50.0% 1/2 • 6 months
Cardiac disorders Sinus bradycardia	50.0% 1/2 • 6 months
Gastrointestinal disorders Vomiting	50.0% 1/2 • 6 months

Additional Information

Dr. Stephen Solomon

Memorial Sloan Kettering Cancer Center

Phone: 212-639-5012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place