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Surgery clinical trials

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NCT ID: NCT06458023 Enrolling by invitation - Surgery Clinical Trials

TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age

Start date: June 10, 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age and when feasible to compare it to standard TOF monitoring using a qualitative monitor.

NCT ID: NCT06334380 Enrolling by invitation - Breast Cancer Clinical Trials

VR for Surgical Prehabilitation and Rehabilitation

VR-PREP
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery.

NCT ID: NCT06266429 Enrolling by invitation - Surgery Clinical Trials

Metabolomic Profiling of Racial Disparity

Start date: March 12, 2024
Phase:
Study type: Observational

Tonsillectomy ± adenoidectomy (T&A) is one of the most common surgical operations with over 500,000 pediatric T&As performed annually in the United States. Unfortunately, despite advances in anesthetic and surgical techniques, moderate-severe post-tonsillectomy pain (PTP) remains a significant problem affecting up to 62% of children. PTP is thought to arise from pharyngeal mucosal inflammation, which produces local nerve irritation and pharyngeal muscle spasm. Patient factors and surgical techniques also play major roles. Race is an important phenotypic risk factor for moderately severe early PTP. The underlying molecular basis of this differential pain experience is presently unknown. This gap in knowledge means that therapies are poorly targeted and often unsuccessful. Indeed, treatment options for PTP have not advanced substantively for many years. Metabolomics provides novel opportunities to investigate common and unique "metabolic signature" of PTP through the analysis of low molecular weight compounds produced in response to tissue injury. Therefore, the central themes of this proposal are that (1) PTP is a complex process that may be determined by molecular level factors such as preoperative systemic inflammation and metabolic profile, and (2) these molecular level factors may explain the excess burden of PTP among minority children. Here the investigators seek to utilize a combined clinical, biological and untargeted metabolomics approach to identify candidate small and large serum molecules that may influence the frequency and severity of PTP in children across racial groups. This approach to exploring the molecular basis of PTP is novel and knowledge from the study should substantially enhance understanding of the mechanisms underlying pediatric PTP - and narrow the racial disparities in post-operative pain.

NCT ID: NCT06232317 Enrolling by invitation - Surgery Clinical Trials

Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients

Start date: December 9, 2023
Phase: N/A
Study type: Interventional

This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.

NCT ID: NCT06184919 Enrolling by invitation - Surgery Clinical Trials

Preparing Older Adults for Major Surgery With Preoperative Comprehensive Geriatric Assessments

Start date: June 14, 2023
Phase:
Study type: Observational

The researchers will conduct observations, interviews, and focus groups with clinicians, staff and patients of the Perioperative Optimization of Senior Health (POSH) clinic, which conducts preoperative comprehensive geriatric assessments (pCGA) at UW Health to understand clinic processes and potential areas for improvement. The goal is to (1) create a process map describing clinic workflow and (2) redesign the process with healthcare providers and patients/families.

NCT ID: NCT06129669 Enrolling by invitation - Surgery Clinical Trials

ICG Indocyanine Green in Reconstructive Surgery

ICG-R
Start date: May 9, 2023
Phase:
Study type: Observational

The success or failure of a reconstruction is largely related to the vascularization of the operated area. Near infrared fluorescence (also near infrared fluorescence angiography, NIR FA) with ICG administration is an innovative technique to quantify tissue perfusion. Based on the results obtained in other subspecialties, NIR fluorescence appears to be a promising way to quantify tissue perfusion in reconstructive surgery. Fluorescence research has previously been used in the context of microsurgery and breast reconstructions using implants, but structural objective determinations are lacking. Our study is successful if we are able to determine a cut off value for the absolute or relative perfusion parameters.

NCT ID: NCT06095362 Enrolling by invitation - Surgery Clinical Trials

Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW

TARGET-beva
Start date: November 29, 2021
Phase: Phase 1
Study type: Interventional

Background: Papillary thyroid cancer (PTC) patients often develop central lymph node metastases (CLNM), which pose a high risk of disease recurrence. The prophylactic central lymph node dissection (PCLND) is controversial, with proponents arguing for it to prevent local recurrence, and opponents objecting to the hypoparathyroidism and nerve damage risk. Currently, no diagnostic tool exists to identify patients who would benefit from a PCLND. Molecular Fluorescence Guided Surgery (MFGS) is a potential solution that uses fluorescent tracers to detect cancerous tissue. This study aims to investigate whether the administration of a GMP-produced near infrared (NIR) tracer, bevacizumab-IRDye800CW, targeting VEGF-A, can enable intraoperative selection of PTC/FTC/HTC patients for CLND. Objective: The primary objective of the study is to determine the optimal dose of bevacizumab-IRDye800CW for an adequate tumor-to-background ratio (TBR) in PTC/FTC/HTC lymph node metastases. The secondary objectives are to evaluate the feasibility of MFGS for PTC/FTC/HTC and nodal metastasis assessment, to correlate and validate fluorescence signals detected in vivo with ex vivo histopathology and immunohistochemistry, to evaluate the distribution of bevacizumab-IRDye800CW on a microscopic level, and to quantify the sensitivity and specificity of bevacizumab-IRDye800CW for PTC/FTC/HTC and nodal metastasis. Study Design: The TARGET-BEVA study is a non-randomized, non-blinded, prospective, single-center phase I feasibility study for patients with confirmed PTC/FTC/HTC, for which the best TBR dosage group in PTC/FTC/HTC nodal metastasis will be determined. The study will initiate with a 3 x 3 scheme: 4,5 mg, 10 mg, and 25 mg, with three patients confirmed with lymph node metastasis in each group. Dosages will be based on previous studies, with the primary objective being the detection of lymph node metastasis. After the first 9 patients, an interim analysis will be performed, after which the best dosage group will be expanded with another 7 patients. Conclusion: The study aims to identify a novel diagnostic tool that can aid clinicians in selecting patients for PCLND, enabling a reduction in overtreatment, morbidity, and costs while maintaining effectiveness with a lower recurrence rate and improved quality of life.

NCT ID: NCT06037837 Enrolling by invitation - Surgery Clinical Trials

Improving Surgeon Performance Measures for Robot-Assisted Surgery

Start date: August 24, 2023
Phase:
Study type: Observational

The purpose of this study is to develop new tools to understand surgeon performance to improve surgical training and participant outcomes after surgery.

NCT ID: NCT05964166 Enrolling by invitation - Surgery Clinical Trials

Tetragraph® Monitor: Tolerance of Preoperative Placement

Start date: May 31, 2023
Phase: N/A
Study type: Interventional

This is a prospective, non-blinded, single arm study. The primary objective of this study is to evaluate the tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.

NCT ID: NCT05932017 Enrolling by invitation - Surgery Clinical Trials

Comparison of Gingival Flap Procedure Using Conventional Surgical Loupes vs. Videoscope for Visualization

Start date: July 1, 2023
Phase:
Study type: Observational

This study is being performed to compare different methods of visualization during routine gum surgery. The gum surgery is standard of care. This study will compare the use of a small camera (videoscope) in conjunction with magnification glasses during surgery vs. surgery only using magnification glasses. Both methods are routinely used and are standard of care methods of visualization. The small camera (videoscope) is a device which allows us to see the area under high magnification and projects live video feed on a computer screen. The study is a split-mouth design pilot study. The patients are only receiving treatment that was previously diagnosed prior to entering the study. The treatment performed is standard treatment that fits in the routine standard of care. No interventional treatment is being performed. The only difference is the method of visualization/observation by the practitioner used during the surgical procedure. One side of the mouth will be treated with just loupes while the other side of the mouth will be treated with loupes and the videoscope.