Lung CancerEMPRESSNCT02323854
The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
A study testing Ablation and Surgical Resection in people with Lung Cancer, run by Medtronic - MITG at 4 sites in 2 countries.
Trial summary
Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Ablation and Surgical Resection
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject or authorized representative has provided informed consent.
- Subject is ≥18 years of age.
- At least one pulmonary metastasis ≤ 3.0 cm in maximum diameter resulting from distant primary cancers or at least one recurrence of primary lung cancer ≤ 3.0 cm in maximum diameter.
- Subject has been confirmed by a thoracic surgeon to be a surgical candidate for resection of the tumor targeted for ablation.
- Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
- ≥1 cm of tumor-free lung parenchyma between target tumor and pleura or fissure.
Who cannot join
- Pre-procedure Exclusion Criteria
- Contraindicated for surgery.
- Prolonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days prior to surgery.
- Tumor abutting main stem bronchus, main pulmonary artery branches, esophagus and/or trachea.
- Tumor with pleural contact.
- Tumors located < 3 cm of staple lines or other metal objects.
Show all 15Show fewer
- Patients diagnosed with GOLD Stage IV Emphysema.
- Uncontrollable coagulopathy
- Patients unable to tolerate discontinued use of anti-coagulants prior to and during the ablation procedure.
- Subject is pregnant (documented by a positive pregnancy test according to hospital standard practices) or is actively breast-feeding.
- Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study.
- The investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
- Patients with implantable pacemakers and other electronic implants, in accordance with Instructions for Use (IFU).
- Intraprocedural Exclusion Criteria
- Incidental intraprocedural finding that the subject no longer meets the study eligibility criteria.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Weill Cornell Medical College
New York, New York, 10065
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors.
Read the detailed description
Primary Endpoint: Dose response as indicated by CT imaging, measurement of maximum diameter and volume.
Secondary Endpoint: Assessment of complete tumor ablation immediately post-procedure.
- Conditions
- Lung Cancer
- Being tested
- Ablation, Surgical Resection
- Keywords
- primary, recurrent, metastatic lung tumor, ablation
- Medical subject headings
- Lung Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
Surgical ResectionProcedure or surgery
The planned surgical resection of the lung tumor will be conducted as scheduled post ablation procedure.
| Study group | Role | What they receive |
|---|---|---|
| Ablation and Surgical Resection | Other | Ablation of lung tumor; followed by surgical resection of the ablation zone. Receives: Device: Ablation; Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Response
Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection.
Measured: 1 Day
Ablation Zone Shape
Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape
Measured: Same day
Secondary outcomes (1)
Number of Participants With Complete or Incomplete Tumor Ablation
The secondary endpoint was complete tumor ablation immediately post-procedure for each target tumor using histologic analysis. Complete ablation was defined as 100% nonviable tumor cells.
Measured: Same Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2015
- Primary completion13 Mar 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Damian E Dupuy, MD FACR, Principal investigator, Lifespan-Rhode Island Hospital, Rhode Island, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323854
- Sponsor's protocol ID
- COVEMPR0437
- Acronym
- EMPRESS
- Status last verified
- Apr 2018
- First submitted
- 13 Dec 2014
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Blackmon SH, Sterner RM, Eiken PW, Vogl TJ, Pua BB, Port JL, Dupuy DE, Callstrom MR. Technical and safety performance of CT-guided percutaneous microwave ablation for lung tumors: an ablate and resect study. J Thorac Dis. 2021 Dec;13(12):6827-6837. doi: 10.21037/jtd-21-594.
PubMed 35070367
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
- ClinicalTrials.gov ID
- NCT02323854
- Acronym / sponsor ID
- EMPRESS / COVEMPR0437
- Conditions
- Lung Cancer
- Keywords
- primary, recurrent, metastatic lung tumor, ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 13 Mar 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 5 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors.
Detailed description
Primary Endpoint: Dose response as indicated by CT imaging, measurement of maximum diameter and volume.
Secondary Endpoint: Assessment of complete tumor ablation immediately post-procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation and Surgical Resection | Other | Device: Ablation, Procedure: Surgical ResectionAblation of lung tumor; followed by surgical resection of the ablation zone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject or authorized representative has provided informed consent.
- Subject is ≥18 years of age.
- At least one pulmonary metastasis ≤ 3.0 cm in maximum diameter resulting from distant primary cancers or at least one recurrence of primary lung cancer ≤ 3.0 cm in maximum diameter.
- Subject has been confirmed by a thoracic surgeon to be a surgical candidate for resection of the tumor targeted for ablation.
- Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
Key exclusion criteria (15 listed)
- Pre-procedure Exclusion Criteria
- Contraindicated for surgery.
- Prolonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days prior to surgery.
- Tumor abutting main stem bronchus, main pulmonary artery branches, esophagus and/or trachea.
- Tumor with pleural contact.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationPercutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed. | Device | Ablation and Surgical Resection |
| Surgical ResectionThe planned surgical resection of the lung tumor will be conducted as scheduled post ablation procedure. | Procedure or surgery | Ablation and Surgical Resection |
Primary outcome
Dose Response
Time frame: 1 Day
Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection.
Ablation Zone Shape
Time frame: Same day
Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape
1 secondary outcome
Number of Participants With Complete or Incomplete Tumor Ablation
Time frame: Same Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35070367Blackmon SH, Sterner RM, Eiken PW, Vogl TJ, Pua BB, Port JL, Dupuy DE, Callstrom MR. Technical and safety performance of CT-guided percutaneous microwave ablation for lung tumors: an ablate and resect study. J Thorac Dis. 2021 Dec;13(12):6827-6837. doi: 10.21037/jtd-21-594.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damian E Dupuy, MD FACR principal investigator
Lifespan-Rhode Island Hospital, Rhode Island, USA
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation and Surgical Resection in people with Lung Cancer, run by Medtronic - MITG at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Response (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.