Phase
Condition
Hernia
Treatment
N/AClinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Pre-Operative Inclusion Criteria:
Age 22 years or older
ASA ≤ 3
The clinical decision has been made to perform multi-port robotic assisted surgerywith da Vinci 5 with Force Feedback instruments for the study specified procedure asprimary procedure prior to enrollment in the study
Subject or a legally authorized representative is able to provide written informedconsent using the study informed consent form prior to the study
Subject is willing and able to comply with the study protocol requirements includingfollow up schedule
Exclusion
Pre-operative Exclusion Criteria:
Subject receiving an emergent procedure
Subject planned to undergo major concomitant surgery for the treatment of adifferent medical condition than was originally planned
Subject with previous ipsilateral surgery (open, endoscopic or robotic) with thesame surgical indication
Subject with past or ongoing medical conditions (for example: inflammatory boweldisease) which, in the judgment of the Investigator, puts them at high risk forsurgery and not appropriate for the study
Subject is pregnant or suspected to be pregnant or breastfeeding
Subject has any other condition or personal circumstance that, in the judgment ofthe Investigator, might interfere with the collection of complete quality data
Subject is currently participating in or has participated in a study of aninvestigational agent or a significant risk investigational device study within thepast 6 months
Subject belongs to a vulnerable population.
Subject is contraindicated for anesthesia or surgery.
Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy,and/or radiation therapy for the treatment of the cancer to be resected within thepast 6 months
Intra-operative Exclusion Criteria
Subject with hemodynamic or respiratory instability, which precludes theInvestigator from performing the RAS.
Subject in whom inadequate visualization makes a minimally invasive approach notfeasible, as determined from the investigator assessment prior to docking the robot.
Subject with adhesions, scarring and disease status in the body which in the opinionof the investigator limits the ability to perform the minimally invasive procedure.
Study Design
Connect with a study center
University of Miami
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
Northeast Georgia Medical Center, Inc
Gainesville 4196586, Georgia 4197000 30501
United StatesActive - Recruiting
Northwestern Memorial Healthcare
Chicago 4887398, Illinois 4896861 60611
United StatesActive - Recruiting
Ohio State University
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
St. David's Healthcare
Austin 4671654, Texas 4736286 78758
United StatesActive - Recruiting

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