N/A
N=50
Levita Magnetic Grasper Device Safety and Performance Study
Benign Gallbladder Disease
Bottom Line
View on ClinicalTrials.gov: NCT02049983 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Sep 2024
Primary outcome: Primary: Safety Assessment of AEs — 50; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Use of Levita Magnetics Grasper (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Levita Magnetics
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Assessment of AEs |
50; 0 | — |
| PRIMARY Feasibility of Mobilization |
50; 45; 5; 0 | — |
Summary
The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.
Eligibility Criteria
Inclusion Criteria
- Patient is between 18 and 60 years of age
- Undergoing elective cholecystectomy due to:
- Cholelithiasis (Gallbladder stones 7mm in size as determined by ultrasound
- Has a gallbladder wall thickness that is > 5mm
- Diabetic Blood coagulation issues
- Has signs of hepatic endocrinology (i.e: cirrhosis, liver failure, increase in liver enzymes, etc.)
- History of endoscopic papillotomy (i.e: Preoperative indication of endoscopic retrograde cholangiopancreatography (ERCP)
- Patient is pregnant or wishes to become pregnant during the length of study participation or lactation
- Patient is not likely to comply with the follow-up evaluation schedule
- Patient is participating in a clinical trial of another investigational drug or device
- Patient is mentally incompetent or a prisoner
- Known or suspected drug or alcohol abuse
- Patient has systemic infection or evidence of any surgical site infection (superficial or organ space)
- Patient has compromised immune system or autoimmune disease (WBC 20,000), including prior or pending treatment for HIV or Hep. C
- Patient intra-operatively needs an additional surgery while undergoing elective cholecystectomy
Data sourced from ClinicalTrials.gov (NCT02049983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.