An observational study in Lung Cancer, sponsored by Intuitive Surgical. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Intuitive Surgical · Observational
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Among 14 studies in Lung Neoplasms by Intuitive Surgical — 4 open to participants now, 7 under way, none of them phase 3. Lung Neoplasms · Intuitive Surgical.
Among the 14 studies in Lung Neoplasms by Intuitive Surgical, this one is the only one that started in 2018, is one of 9 observational ones, and was the 1st registered.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
Browse Lung Neoplasms studies →4 of the 14 studies in Lung Neoplasms by Intuitive Surgical are open now, in 8 countries. Recruiting first, the newest first:
Intuitive Surgical · Sites in Germany, Switzerland, United Kingdom
Ages 18+
Intuitive Surgical · Sites in France, Germany, Switzerland and 1 more country
Ages 18+
Intuitive Surgical · Sites in Denmark, France, Germany and 4 more countries
Ages 18+
Intuitive Surgical · Sites in Korea, Republic of
Ages 19+
By country, each count listing its studies:
Of the 996 Lung Neoplasms studies recruiting now, 683 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.
This study: 18 Years and older · all sexes.
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14 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 1 started in 2018.
This study's enrollment of 7,000 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.
Median enrollment 354 across the 5 interventional studies, 288 across the 9 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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Intuitive Surgical is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
1 of the studies in Lung Neoplasms by Intuitive Surgical that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06004440Intuitive SurgicalReal World Registry for Use of the Ion Endoluminal System | 2027-08 |
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Among the 14 studies in Lung Neoplasms by Intuitive Surgical, from their registry updates:
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The main objective of this study is to evaluate and compare peri-operative outcomes of lobectomy compare with different approaches. The study aims to include patients with stage IA, IB, IIA, IIB and IIIA lung cancer that underwent lobectomy via robotic-assisted, VATS and open approach.
This is a multi-center, retrospective chart review study of all consecutive lobectomies performed for clinical stage IA, IB, IIA, IIB and IIIA lung cancer, performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of lobectomy performed for clinical stages, IA, IB, IIA, IIB and IIIA lung cancer via robotic-assisted, VATS (video assisted thoracic surgery) and open approach that meet the study inclusion and exclusion criteria will be considered for inclusion in the study. The chart review and data collection will be performed in a reverse chronological order starting at 30 days prior to IRB approval of the study at the institution and going back to 2013 (i.e most current data in 2017 and chronologically going back through 2013). The retrospective chart review and data collection is anticipated to occur in two phases:
Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes data will be obtained from hospital records. Each participating institution will contribute approximately 100-800 cases from one or more surgeons. Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment and no patient consenting is required
Patients who underwent robotic-assisted, VATS or open lobectomy for primary stage IA, IB, IIA, IIB and IIIA lung cancer, with or without neo-adjuvant therapy.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent robotic-assisted lobectomy for lung cancer.
Procedure: Robotic-assisted lobectomy using da Vinci Surgical System
Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent VATS lobectomy for lung cancer.
Procedure: VATS (video assisted thoracic surgery)
Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent open lobectomy for lung cancer.
Procedure: Open lobectomy
Robotic-assisted lobectomy
VATS (video assisted thoracic surgery)
Open lobectomy
Chart review and data collection of clinical stage IB, IIA, IIB, IIIA cases
Compare peri-operative outcomes of robotic-assisted lobectomy with those associated with VATS and open lobectomy for lung cancer
Time frame: 2013-2019
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jul 2020, 29 months.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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