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ANET Electrosurgery Applicator Pilot Evaluation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400748
Recruitment Status : Terminated (business reason)
First Posted : January 17, 2018
Results First Posted : September 27, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Spiration, Inc.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 23, 2018
Actual Primary Completion Date : November 18, 2020
Actual Study Completion Date : November 18, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. ANET Related Peri-procedural Adverse Events [ Time Frame: Day 0 ]
    The incidence of reported adverse events and serious adverse events related to the ANET device or procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400748


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Spiration, Inc.
  Study Documents (Full-Text)

Documents provided by Spiration, Inc.:
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Responsible Party: Spiration, Inc.
ClinicalTrials.gov Identifier: NCT03400748    
Other Study ID Numbers: 15
First Posted: January 17, 2018    Key Record Dates
Results First Posted: September 27, 2021
Last Update Posted: September 27, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: 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:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases