Adenoma Clinical Trial
Official title:
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.
This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice. PRIMARY OBJECTIVES: I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues. II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries. III. Assess the impact of PTeye on minimizing risk of post-surgical complications. Participants will be randomized to either the experimental or control arm. The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the PTeye will indicate to the surgeon if the tissue is likely parathyroid or not. For patients assigned to the control arm, the surgeon will not use the PTeye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. Participants will be follow-ed up for up to 6 months after surgery. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Recruiting |
NCT02545699 -
Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy
|
N/A | |
Completed |
NCT01802008 -
Comparison of Adenoma Detection Miss Rates at Colonoscopy Associated With Different Withdrawal Times
|
N/A | |
Recruiting |
NCT01211132 -
Cap Assisted Colonoscopy for the Detection of Colon Polyps
|
N/A | |
Completed |
NCT04287335 -
Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China
|
||
Not yet recruiting |
NCT06398418 -
R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05362344 -
Colorectal Cancer Screening in Cystic Fibrosis
|
||
Completed |
NCT03268200 -
The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy
|
N/A | |
Recruiting |
NCT04591145 -
Multi-center Validation of a Deep Learning Based Bowel Preparation Evaluation System
|
||
Completed |
NCT02978664 -
The Impact of Distraction on Adenoma Detection Rate
|
N/A | |
Completed |
NCT00018551 -
Chemoprevention With Folic Acid
|
Phase 2 | |
Recruiting |
NCT05594576 -
Comparison of the ENDOCUFF VISION® Endoscopy Cap Coupled With GI GENIUS™ Artificial Intelligence Compared to Each Device Alone in Improving Colonic Adenoma Detection Rate During Colonoscopy
|
N/A | |
Not yet recruiting |
NCT04135716 -
A Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy
|
N/A | |
Recruiting |
NCT02552017 -
Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
|
N/A | |
Recruiting |
NCT02288962 -
Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas
|
Phase 3 | |
Completed |
NCT02066064 -
G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist
|
N/A | |
Completed |
NCT01749722 -
Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
|
N/A | |
Completed |
NCT01485133 -
Water Method Colonoscopy in Patients With Prior Surgery
|
N/A | |
Withdrawn |
NCT01546259 -
Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy
|
N/A | |
Withdrawn |
NCT01546246 -
Water Method in Patients With Incomplete Colonoscopy
|
N/A |