Real World Registry for Use of the Ion Endoluminal System
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06004440 |
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Recruitment Status :
Recruiting
First Posted : August 22, 2023
Last Update Posted : March 22, 2024
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Sponsor:
Intuitive Surgical
Information provided by (Responsible Party):
Intuitive Surgical
- Study Details
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Brief Summary:
The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.
| Condition or disease | Intervention/treatment |
|---|---|
| Lung Cancer Multiple Pulmonary Nodules Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases | Device: Ion Endoluminal System |
This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield.
Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 3000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System |
| Actual Study Start Date : | September 21, 2023 |
| Estimated Primary Completion Date : | August 2026 |
| Estimated Study Completion Date : | August 2027 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System
Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.
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Device: Ion Endoluminal System
Subjects will under a planned procedure with the Ion Endoluminal System |
Primary Outcome Measures :
- Primary Endpoint to Assess Diagnostic Yield [ Time Frame: Intra-procedure through the 24 month follow up period ]Defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.
Secondary Outcome Measures :
- Secondary Endpoint to Assess Pneumothorax [ Time Frame: Intra-procedure through the 30 day follow up period ]Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention
- Secondary Endpoint to Assess Bleeding [ Time Frame: Intra-procedure through the 30 day follow up period ]Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale
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 |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects scheduled for an elective pulmonary lesion biopsy or localization procedure using the Ion Endoluminal System, 18 years or older
Criteria
Inclusion Criteria:
- Subject is 18 years or older at the time of the index procedure.
- Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
- Subject able to understand and adhere to study requirements and provide informed consent.
Exclusion Criteria:
- Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord.
- Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study.
- Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices.
- Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.
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): NCT06004440
Contacts
| Contact: Heather Golden, MSc, CCRP | 8105697006 | heather.golden@intusurg.com | |
| Contact: Lindsay Seibel, BSc | Lindsay.Seibel@intusurg.com |
Locations
| United States, California | |
| University of California Davis Medical Center | Not yet recruiting |
| Davis, California, United States, 95616 | |
| Contact: Tina Tham, CCRP | |
| Principal Investigator: Chinh Phan, DO | |
| United States, Florida | |
| Orlando Health Orlando Regional Medical Center | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Kathleen Sanders, MBA, CCRP | |
| Principal Investigator: Ali Z. Jiwani, MD | |
| United States, Illinois | |
| Ascension Alexian Brothers | Recruiting |
| Elk Grove Village, Illinois, United States, 60007 | |
| Contact: Diana Sullivan, MS, RN | |
| Principal Investigator: Neeraj Desai, MD | |
| United States, Kansas | |
| Kansas University Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66103 | |
| Contact: Jamie Quigley, RRT, CCRC | |
| Principal Investigator: Maykol Postigo, MD | |
| United States, Michigan | |
| Henry Ford Hospital | Not yet recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Sherae Hereford, RN | |
| Principal Investigator: A. Rolando Peralta, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55902 | |
| Contact: Karly Pierson, RN, CCRP | |
| Principal Investigator: Janani Reisenauer, MD | |
| United States, North Carolina | |
| Cone Health Moses Cone Memorial Hospital | Recruiting |
| Greensboro, North Carolina, United States, 27401 | |
| Contact: Iulia Basaraba, MD | |
| Principal Investigator: Bradley Icard, DO | |
| FirstHealth Moore Regional Hospital | Recruiting |
| Pinehurst, North Carolina, United States, 28374 | |
| Contact: Julie Williams, PhD, MPH | |
| Principal Investigator: Michael Prichett, DO, MPH | |
| United States, Ohio | |
| Ohio State University Wexner Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Amy Miller | |
| Principal Investigator: Alberto Revelo, MD | |
| United States, Tennessee | |
| Centennial Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Sean O'Malley, RN, BSN | |
| Principal Investigator: Susan Garwood, MD | |
| United States, Texas | |
| Methodist Hospital | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Samantha Franklin | |
| Principal Investigator: Ali Abedi, MD, MSc | |
| United States, Utah | |
| Intermountain Medical Center | Not yet recruiting |
| Murray, Utah, United States, 84107 | |
| Contact: Valerie Aston, MBA, CCRP | |
| Principal Investigator: Timothy LeClair, MD | |
| United States, Wisconsin | |
| Aurora Medical Center Kenosha | Not yet recruiting |
| Kenosha, Wisconsin, United States, 53143 | |
| Contact: Dina Yassen, MBBS | |
| Principal Investigator: Hasnain Bawaadam, MD, MPH | |
Sponsors and Collaborators
Intuitive Surgical
Investigators
| Study Chair: | Janani Reisenauer, MD | Mayo Clinic | |
| Study Chair: | Michael Pritchett, DO, MPH | FirstHealth of the Carolinas |
| Responsible Party: | Intuitive Surgical |
| ClinicalTrials.gov Identifier: | NCT06004440 |
| Other Study ID Numbers: |
IntuitiveSurgical |
| First Posted: | August 22, 2023 Key Record Dates |
| Last Update Posted: | March 22, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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.: | No |
Keywords provided by Intuitive Surgical:
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pulmonary biopsy pulmonary lesion localization shape sensing robotic assisted bronchoscopy ION Intuitive |
Additional relevant MeSH terms:
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Neoplasms Lung Neoplasms Multiple Pulmonary Nodules Neoplasms by Site |
Thoracic Neoplasms Respiratory Tract Neoplasms Lung Diseases Respiratory Tract Diseases |