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During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

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Search Results 1-6 of 6 for Bronchoscopy

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  1. NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

    Rochester, MN

    NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      IV
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 11-006769

    • NCT ID:

      NCT01394978

    • Sponsor Protocol Number:

      NEO09-100

  2. Evaluation of the Spiration Valve for Emphysema to Improve Lung Function

    Jacksonville, FL

    Evaluation of the Spiration Valve for Emphysema to Improve Lung Function

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    This is a multicenter, prospective, randomized, controlled study designed to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.

    The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Jacksonville, Fla.

    Closed for enrollment

    		View complete study & contact information
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    • Site IRB:

      • Jacksonville, Florida: 13-002690

    • NCT ID:

      NCT01812447

    • Sponsor Protocol Number:

      CPR-03434

  3. A Study to Evaluate the Clinical Utility for the Ion™ Endoluminal System

    Rochester, MN

    A Study to Evaluate the Clinical Utility for the Ion™ Endoluminal System

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to evaluate the clinical utility and early performance of the FDA cleared Ion™ Endoluminal System (“Ion”) for brochoscopically approaching and facilitating the sampling of peripheral pulmonary nodules, between 1-3cm in size, of unknown etiology.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 18-011348

    • Sponsor Protocol Number:

      18-011348

  4. The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors

    Rochester, MN

    The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    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.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 15-001772

    • NCT ID:

      NCT02323854

    • Sponsor Protocol Number:

      COVEMPR0437

  5. MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)

    Rochester, MN

    MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to evaluate if lung ablation improves clinical outcomes for patients deemed to be surgically high-risk.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 15-001758

    • NCT ID:

      NCT02673021

    • Sponsor Protocol Number:

      15-001758

  6. A Study Identifying Predictive Biomarkers for the Progression of Invasive Squamous Cell Carcinoma

    Rochester, MN

    A Study Identifying Predictive Biomarkers for the Progression of Invasive Squamous Cell Carcinoma

    • Location:

      Observational

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The study will utilize both retrospective and prospective data collection from patients that already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection for squamous cell carcinoma. The investigators plan to prospectively collect 5 bronchoscopic biopsies, 3ml blood and one tumor and adjacent normal samples from 200 qualified patients who meet the study criteria.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 15-000548

    • NCT ID:

      NCT02549638

    • Sponsor Protocol Number:

      15-000548
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