ANET Electrosurgery Applicator Pilot Evaluation Study

• Sponsor: Spiration, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03400748
• Collaborator: (none)
• Enrollment: 6
• Locations: 4
• Arm: 1
• Actual Duration (Months): 30.9
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Lung Cancer Metastatic	Device: RF Ablation	N/A

Detailed Description

This study is a prospective, single arm, single center study that will evaluate the effectiveness of the ANET Electrosurgery Applicator in up to 10 subjects.

Subjects who consent to participate in this study will have a lung tumor that is scheduled to be removed surgically as part of their normal treatment. During the surgical procedure, just prior to resection the subject's tumor will be treated with the ANET device. The ANET device uses a bronchoscope to reach the tumor. Ultrasound on the bronchoscope, CT, and X-rays are used to make sure the ANET device is in the tumor. Once in the tumor, the ANET device uses radio-frequency (RF) ablation to treat the tumor. After standard surgical resection the tumor and surrounding tissue is evaluated to characterize the effect of the ANET.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: ANET Electrosurgery Applicator Pilot Evaluation Study
• Actual Study Start Date: Apr 23, 2018
• Actual Primary Completion Date: Nov 18, 2020
• Actual Study Completion Date: Nov 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RF Ablation Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection.	Device: RF Ablation; The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.

Outcome Measures

Primary Outcome Measures

1. ANET Related Peri-procedural Adverse Events [Day 0]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor

2. Pathological proof of target nodule/tumor type and malignancy

3. Target nodule/tumor which can be accessed via EBUS bronchoscopy

4. Resection/surgical candidate

5. Participants must be at least 18 years old and able to provide consent

Exclusion criteria:

1. Subjects in whom flexible bronchoscopy is contraindicated

2. Target nodule < 1.0 cm

3. Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor

4. Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives

5. Pacemaker, implantable cardioverter, or other electronic implantable device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	Duke University Medical Center	Durham	North Carolina	United States	27710
3	UT MD Anderson Cancer Center	Houston	Texas	United States	77030
4	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

• Spiration, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan: Canada - Jun 1, 2020
• Study Protocol and Statistical Analysis Plan: United States - Sep 11, 2020

More Information

Publications

None provided.

• Responsible Party: Spiration, Inc.
• ClinicalTrials.gov Identifier: NCT03400748
• Other Study ID Numbers: 15
• First Posted: Jan 17, 2018
• Last Update Posted: Sep 27, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Spiration, Inc.: Electrosurgery; RF ablation; Minimally invasive; Lung cancer; Lung metastasis; Lung tumor; Primary; Metastatic; Endobronchial ultrasound; EBUS
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

Participant Flow

Arm/Group Title	RF Ablation
Arm/Group Description	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.
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	RF Ablation
Arm/Group Description	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 Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 33.3%
>=65 years	4 66.7%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	71
Sex: Female, Male (Count of Participants)
Female	3 50%
Male	3 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 33.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	4 66.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Canada	5 83.3%
United States	1 16.7%

Outcome Measures

1. Primary Outcome

Title	ANET Related Peri-procedural Adverse Events
Description	The incidence of reported adverse events and serious adverse events related to the ANET device or procedure
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RF Ablation
Arm/Group Description	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.
Measure Participants	6
Number [Adverse Event]	0

Adverse Events

Time Frame	Day 0
Arm/Group Title	RF Ablation
Arm/Group Description	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.
All Cause Mortality
	RF Ablation
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	RF Ablation
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	RF Ablation
	Affected / at Risk (%)	# Events
Total	0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.