Trial Outcomes & Findings for ANET Electrosurgery Applicator Pilot Evaluation Study (NCT NCT03400748)

Last Updated: 2024-04-03

Results Overview

The incidence of reported adverse events and serious adverse events related to the ANET device or procedure

Recruitment status

TERMINATED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Day 0

Results posted on

2024-04-03

Participant milestones
Measure	RF Ablation Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection. RF Ablation: The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Withdrawal data not reported

ANET Electrosurgery Applicator Pilot Evaluation Study

Baseline characteristics by cohort
Measure	RF Ablation n=6 Participants Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection. RF Ablation: The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	5 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

Timeframe: Day 0

The incidence of reported adverse events and serious adverse events related to the ANET device or procedure

Outcome measures
Measure	RF Ablation n=6 Participants Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection. RF Ablation: The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.
ANET Related Peri-procedural Adverse Events	0 Adverse Event

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Spiration, Inc.

Phone: 425-636-5464

Restriction type: LTE60