Lung Diseases Clinical Trial
Official title:
A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies
Verified date | December 2015 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. All patients with mesothelioma or other pathologies undergoing a pleurectomy decortication at MD Anderson Cancer Center 2. Adequate preoperative renal function documented by serum creatinine of < 1.5 mg/dl or calculated creatinine clearance > 50 ml/min Exclusion Criteria: 1. Patients unable to consent for the procedure 2. Patients with a history of allergy to human proteins 3. Patients who may have insufficient renal capacity for clearance of Progel® polyethylene glycol load |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Bard Incorporated |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Resolve Air Lung Leak After Pleurectomy Decortication | Primary outcome is T = time to resolve an air leak in the lungs, allowing the possibility that an air leak may not develop, represented by T=0. | Participants followed for the duration of hospital stay, at least 5 days. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05563701 -
Evaluation of the LVivo Image Quality Scoring (IQS)
|
||
Completed |
NCT04908397 -
Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension
|
Phase 1 | |
Terminated |
NCT03309358 -
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
|
Phase 1 | |
Completed |
NCT03682354 -
ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery
|
N/A | |
Enrolling by invitation |
NCT03683186 -
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
|
Phase 3 | |
Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
|
N/A | |
Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Completed |
NCT02926768 -
Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01443845 -
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
|
Phase 4 | |
Completed |
NCT00269256 -
Stress, Environment, and Genetics in Urban Children With Asthma
|
N/A | |
Completed |
NCT00281216 -
Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations
|
N/A | |
Terminated |
NCT00233207 -
IC14 Antibodies to Treat Individuals With Acute Lung Injury
|
Phase 2 | |
Recruiting |
NCT00129350 -
Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation
|
Phase 1 | |
Active, not recruiting |
NCT00115297 -
Montelukast for Early Life Wheezing
|
Phase 2/Phase 3 | |
Completed |
NCT00094276 -
Intervention for Improving Asthma Care for Minority Children in Head Start
|
N/A | |
Completed |
NCT00091767 -
Genetic Studies in Difficult to Treat Asthma: TENOR
|
N/A | |
Completed |
NCT00089752 -
Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea
|
N/A | |
Completed |
NCT00069823 -
Study of Acid Reflux in Asthma
|
Phase 3 | |
Completed |
NCT00083798 -
Family Linkage Study of Obstructive Sleep Apnea (OSA) in Iceland
|
N/A |