Clinical Trials Logo
  1. Home
  2. Thoracic
  3. NCT01476761

MicroCutter in Surgical Stapling - European Trial I — MET1  

Thoracic Clinical Trial

Official title:
The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study

Clinical Trial Summary

The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in a post-market approval study.

Clinical Trial Description

A prospective, open label, multi-center non-inferiority safety study with an all-comers enrollment of patients requiring surgical stapling of the stomach and/or intestine according to the labeled indications contained in the approved labeling. Up to 178 subjects consented for a 1-month clinical follow-up evaluation will be enrolled. Primary endpoint is to statistical non-inferiority of composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) in study patients when compared to composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) as derived from a comprehensive analysis of the medical literature. The comparison will be performed for cumulative events up to 30 days postoperatively. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01476761
Study type Interventional
Source Cardica, Inc
Contact
Status Completed
Phase Phase 4
Start date November 2011
Completion date July 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT06049264 - Thoracic Spine Manual Traction With Mobilization Versus Manipulation N/A
Completed NCT04251637 - Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery
Withdrawn NCT05100160 - Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial) Phase 3
Not yet recruiting NCT04546594 - Epidemiological Data on Pain
Terminated NCT03962036 - Effect of One-lung Ventilation on BIS Values
Completed NCT05091281 - Macintosh Versus GlideScope Versus C-MAC for Double Lumen Endotracheal Intubation N/A
Completed NCT05091398 - Erector Spinae Plane, Paravertebral Versus Intercostal Nerve Block for VATS Surgery N/A
Active, not recruiting NCT06252740 - Investigation of Regional Interdependence of the Hip and Spine in Baseball Players With Low Back Pain
Recruiting NCT06075316 - Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS) N/A
Completed NCT05395078 - Effects of Thoracic Extension Versus Thoracic Stabilization Exercises in Patients With Maigne's Thoracic Pain N/A
Completed NCT05392517 - Effects of Self-mobilization Techniques in Chronic Thoracic Pain N/A
Active, not recruiting NCT05798585 - Comparing Erector Spinae Plane (ESP) and Thoracic Paravertebral (TPV) Block Analgesic Effect After Elective VATS N/A
Not yet recruiting NCT06253741 - Rhomboid Intercostal and Subserratus / Paravertebral Block N/A
Completed NCT05204537 - The Role of Surgery in Patients With Coronavirus Disease - 19 (COVID-19) Related Thoracic Complications
Completed NCT04246099 - Opioid-free Anesthesia in Thoracic Surgery
Terminated NCT02259452 - Radiation Induced Cardiopulmonary Injury in Humans
Completed NCT03708198 - Pharmacokinetics of Single-Dose Liposomal Bupivacaine in Surgeon Performed Intercostal Nerve Blocks Phase 4
Completed NCT04964973 - Effect of Transcutaneous Electro-stimulation in Ambulatory Postoperative Rehabilitation Treatment in Thoracic Surgery. N/A
Completed NCT06310850 - The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety Phase 3
Completed NCT03836183 - Pleuropulmonary Ultrasound With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation N/A