Trials / Completed
CompletedNCT01307501
Safety and Efficacy of Cryoablation for Metastatic Lung Tumors
Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.
Detailed description
ECLIPSE is a treatment, Phase 1 multicenter, prospective, single-arm study with participants serving as their own control. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 cm. Participants will be followed for 5 years post their cryoablation procedure. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal), and urology (kidney).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cryoablation | Application of extremely cold temperatures to the identified tumor(s). |
Timeline
- Start date
- 2012-01-04
- Primary completion
- 2018-08-30
- Completion
- 2018-08-30
- First posted
- 2011-03-03
- Last updated
- 2021-07-19
- Results posted
- 2019-10-01
Locations
4 sites across 2 countries: United States, France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01307501. Inclusion in this directory is not an endorsement.