Clinical Trials Logo
  1. Home
  2. Lung Diseases
  3. NCT02668978
  4. Details
NCT02668978 Clinical Trial

SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH

LUNG DISEASES Clinical Trial

Official title:
Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection With Hemopatch™ Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02668978
Other study ID # SEALLS
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2016
Est. completion date August 31, 2019

Study information
Verified date August 2019
Source Quirón Madrid University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques.

Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients over the age of 18 years who are able to give their informed consent

- Patients undergoing lung resection surgery for either malignant or benign conditions including:

- Lobar and sublobar resections

- Open, video-assisted thoracoscopic or robotic surgeries

- Diagnostic or therapeutic procedures

Exclusion Criteria:

- Traumatic pulmonary contusion or laceration

- Lung reduction surgery

- Planned removal of more than 10 lung lesions

- Pneumonectomy

- Known hypersensitivity to bovine protein

- Known hypersensitivity to Brilliant Blue FCF (E133)

- Presence of active infection

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Hemopatch™ Sealing Hemostat
Hemopatch™ application over lung resection areas
Procedure:
• Standard surgical technique
Lung resuturing or restapling

Locations
Country Name City State
Spain Quirónsalud Madrid University Hospital Pozuelo de Alarcón Madrid

Sponsors (2)
Lead Sponsor Collaborator
Quirón Madrid University Hospital Baxter BioScience

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of postoperative air leaks Duration of postoperative lung air leaks expressed in hours Within first 30 postoperative days
See also
  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 NCT00281216 - Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations N/A
Completed NCT00269256 - Stress, Environment, and Genetics in Urban Children With Asthma 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 NCT00083798 - Family Linkage Study of Obstructive Sleep Apnea (OSA) in Iceland N/A
Completed NCT00069823 - Study of Acid Reflux in Asthma Phase 3
Completed NCT00089752 - Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea N/A