Treatment Trials

15 Clinical Trials for Various Conditions

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RECRUITING
Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Description

The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.

WITHDRAWN
Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy
Description

The study will compare the outcomes of patients with gallstone related cholecystitis who are poor surgical candidates undergoing EUS guided cholecystoenterostomy via a lumen apposing metal stent (LAMS).

COMPLETED
AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
Description

To evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced Delivery System in the management of symptoms of acute cholecystitis as an alternative to percutaneous gallbladder drainage.

COMPLETED
Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy
Description

This study looks at the differences in inflammatory mediators in gallbladder tissue between males and females and the possibility that these differences contribute to a higher perception of post-operative pain in females following laparoscopic cholecystectomy.

TERMINATED
Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
Description

This study evaluates operative and non-operative management of acute appendicitis (infection or inflammation of the appendix) and acute cholecystitis (inflammation/infection of the gallbladder) in patients with active mild to moderate COVID-19 infection. The hypothesis is that COVID+ patients with uncomplicated acute appendicitis or acute cholecystitis amendable to a laparoscopic procedure can have safe operative outcomes compared to those managed non-operatively.

UNKNOWN
Subtotal Cholecystectomy for Complicated Acute Cholecystitis: a Multicenter Prospective Observational Study
Description

We believe that subtotal cholecystectomy is a safe alternative to total cholecystectomy when the complicated gallbladder is encountered, resulting in decreased or equivalent risk of bile duct injury, major vascular injury, postoperative hemorrhage, infectious complications, and mortality. Additionally, we hope to further elucidate the expected outcomes of the varying subtypes of subtotal cholecystectomy in order to determine the safest approach, assuring the lowest need for secondary intervention, recurrent biliary disease, or need for a completion cholecystectomy.

COMPLETED
Functional MRC With Eovist for Acute Cholecystitis
Description

Functional magnetic resonance cholangiography (fMRC) with gadoxetate disodium (Eovist) is an accurate method of diagnosing acute cholecystitis.

COMPLETED
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study
Description

The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

ENROLLING_BY_INVITATION
Safety and Feasibility of ActivSightTM in Human
Description

ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively. Primary Objective: To determine safety and feasibility of ActivSightTM in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery. Secondary Objective: To determine the efficacy of ActivSightTM in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (ICG) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using ICG-based intraoperative cholangiography (IOC).

COMPLETED
Evaluation of Closed-loop TIVA Propofol, Sufentanil and Ketamine Guided by BIS Monitor
Description

The purpose of this study is to compare a closed-loop intravenous anesthetic using Bispectral Index as a feedback loop and a controller based on reinforcement learning to titrate dose and intravenous anesthetic that is manually controlled or a standard volatile anesthetic agent titrated by the anesthesiologist to determine improvement in the following parameters as compared to controls: time to discharge from the Post Anesthesia Care Unit, post-operative nausea and vomiting, pain scores and sedation scores.

ENROLLING_BY_INVITATION
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
Description

This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.

ENROLLING_BY_INVITATION
Fetal Outcomes Among Pregnant Emergency General Surgery Patients
Description

Approximately 1 in 500 pregnant women require non-obstetric surgery. Surgical care for the pregnant woman raises concern for complications adversely affecting pregnancy outcomes. The most common reason for surgery is acute appendicitis followed by gallbladder disease. Despite the common incidence of non-obstetric surgery among pregnant women, little is known regarding fetal outcome and the impact of laparoscopic interventions versus traditional open procedures. Even less is known about the role of non-operative management of general surgical disease in the pregnant population. However, fetal outcome is not compromised by emergency general surgery condition interventions.

COMPLETED
Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
Description

This VA QUERI Partnered Evaluation Initiative will evaluate the impact of an immersive Point-of-care Ultrasound (POCUS) Training Course on provider skill acquisition and retention; the frequency of POCUS use by trained providers; and the barriers/facilitators to POCUS in the VHA. Data sources include pre- and post-course assessment tools, medical coding data, and course evaluations. Providers that participate in the POCUS Training Course will be compared to control providers from wait-listed facilities. Additionally, participating facilities vs. wait-listed facilities for the POCUS Training Course will be compared. Findings from this project will guide ongoing efforts of the investigators' operating partners, VA Specialty Care Centers of Innovation (SCCI) and the VA Simulation Learning and Research Network (SimLEARN), to develop a national POCUS training program and facilitate implementation of POCUS use system-wide in the VA healthcare system.

SUSPENDED
Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
Description

This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect clinical decision making. The study will evaluate risk factors and co-variants, including genetic variants that are associated with disease progression such as pain, inflammation, organ dysfunction, disability and quality of life.

COMPLETED
Prognostic Indicators as Provided by the EPIC ClearView
Description

The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known diagnoses identified by medical doctors. Specifically, the investigators hypothesize that the organ system involving any of a series of known active diagnoses will be identified in the EPIC ClearView Response Scale report with the intention of providing potential triage capabilities.