Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

A min. of 800 patients referred to colonoscopy at Aalborg University Hospital. The 800 patients are from the out patient clinic. A mix of screening and non-screening patients.

No intervention is made other than following existing guidelines for colonoscopy. Further treatment and/or renewed colonoscopy in case of positive findings follows existing guidelines. The group is used only used to collect quality assurance data.

No intervention, purely observational.

Lasse Pedersen, m.d.

The study aim is to investigate factors associated with patient satisfaction during a colonoscopy.

The study aim to capture key quality indicators and patient satisfaction for 800 patients referred for a colonoscopy at Aalborg University Hospital. The patient population is mix of screening and non-screening colonoscopies seen at our out-patient clinic.

Each Colonoscopy is registered using a specially designed registration form and a more detailed form relating to the colonoscopy itself. The data collected includes: The Colonoscopist endoscopy experience and education, Medicine use, Colonoscopy duration, Unadjusted Caecum Intubations rate, Polyp detection rate, Polyps removed, Cancer detection rate and Nurse assisted Gloucester Comfort score.

Patient level data were recorded using a questionaire with 6 questions regarding satisfaction, pain, discomfort etc on a 10 cm analog scale.

Patient Satisfaction With Colonoscopy in a Danish Setting - What Are the Most Important Factors?

Each patient were given a questionaire with 6 questions answering satisfaction, pain, discomfort etc on a 10 cm analog scale.

Nordsim

Aalborg University Hospital

MD, Ph.D.-student

Colonic Neoplasms

Colometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist.

An identical set-up to the experimental arm but with a green band showing across the top for the duration of the colonoscopy.

Recordings of colonoscopies made without Colometer or sham feedback during the course of the colonoscopy will be evaluated retrospectively using the Colometer software.

Real time software based image analysis tool.

Colometer

Software that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy.

Sham Software

Christopher N Andrews, MD MSc

Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.

Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy

This is defined as the Percentage of the total withdrawal time where the withdrawal velocity is below a set speed limit and the view is clear (ie, not blurry) as measured by the software. Visualization of the colon lumen is ideal with a slow, non-blurry view in order to detect polyps.

Christopher Andrews

Associate Professor

Adenoma

Colonoscopies performed at a VA facility with computer assisted detection (CADe) artificial intelligence available.

Colonoscopies performed at a VA facility without CADe artificial intelligence available

Computer-aided polyp detection system that utilizes artificial intelligence (AI) during colonoscopy

Computer Assisted Detection

Jason A. Dominitz, MD, MHS

The purpose of this study is to evaluate the effect of artificial intelligence systems used during colonoscopy on the detection of precancerous polyps in the colon.

Colonoscopy is a key diagnostic and therapeutic procedure for the prevention of colorectal cancer incidence and mortality. Central to colonoscopy's effectiveness is the identification and removal of colorectal neoplasia, including adenomatous polyps and sessile serrated lesions. The endoscopist's adenoma detection rate (ADR), classically defined as the proportion of screening colonoscopies in which one or more adenomas are detected, has been demonstrated to be strongly inversely associated with their patients' risk of post-colonoscopy colorectal cancer. Therefore, improving adenoma detection is a major target of quality assurance efforts.

In 2022, the FDA approved the first artificial intelligence (AI) system for computer assisted detection (CADe) of colorectal neoplasia (also known as colorectal polyps). These CADe devices project an image on the endoscopy monitor (i.e., a bounding box) to alert the endoscopist to the presence of a suspected polyp within the colon. Initial studies, including randomized controlled trials, have demonstrated that use of CADe systems result in a significant improvement in adenoma detection, with a reduction in the miss rate of adenomas (i.e., fewer adenomas are found on a second colonoscopy when the first colonoscopy was performed with a CADe system compared to when the first colonoscopy did not use CADe). However, more recent studies have not demonstrated a clear benefit of these devices. Moreover, most of the additional adenomas that are detected are diminutive polyps, the vast majority of which are thought to be of minimal, if any, clinical significance. When multiple adenomas are detected during colonoscopy, current guidelines recommend repeating colonoscopy sooner than would otherwise be recommended. Also, the CADe systems may have unintended consequences, such as creating alert fatigue through false alarms or negatively impacting training of gastroenterology fellows.

As part of ongoing quality assurance efforts, the Veterans Health Administration's (VHA) National Gastroenterology and Hepatology Program (NGHP) purchased over 100 Medtronic GI Genius CADe devices in late 2022. As funds were not available to supply the CADe systems to all VHA medical centers, these devices were allocated to randomly selected medical centers across the United States.

With the introduction of the CADe devices within the VHA, the NGHP will evaluate the quantitative and qualitative impact and outcomes of use of CADe within VHA medical centers. The NGHP has built a colonoscopy quality dashboard that reports adenoma detection rates for facilities and individual endoscopists at VHA medical centers. For select medical centers, additional quality metrics are also available (e.g., colonoscope withdrawal time, adenomas per colonoscopy, polyps per colonoscopy).

Using these data, outcomes will be compared within facilities (i.e., pre- vs. post-CADe) and between facilities (i.e., facilities with CADe vs. facilities without CADe). Endoscopists at medical centers with CADe devices will be surveyed and interviewed about their use of and satisfaction with these devices.

The initial evaluation will compare outcomes at the facility level. Subsequent analyses will compare outcomes at the individual endoscopist level.

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)

Change in the adequacy of bowel preparation during colonoscopy using either the Boston Bowel Prep Scale (0-9, where 9 is best) or the Aronchick Scale (Poor to Excellent)

Change in the proportion of colonoscopies in which one or more adenomas are detected

Change in the duration of colonoscope withdrawal when no intervention (e.g., polypectomy, biopsy) is performed

Change in the duration of colonoscope withdrawal irrespective of interventions

Change in the number of adenomas detected per colonoscopy

Change in the proportion of colonoscopies where one or more adenomas are detected

Change in the number of polyps detected per colonoscopy

Provider ratings of satisfaction with the CADe device

Change in the proportion of colonoscopies where colorectal cancer is detected

VA Salt Lake City Health Care System

San Francisco Veterans Affairs Medical Center

VA Puget Sound Health Care System

Executive Director, National Gastroenterology and Hepatology Program

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Use of US for post implant quality assessment

transrectal ultrasound

Francois Bachand, MD

Post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. CT imaging is the standard of assessment but due to contouring uncertainties, MR-CT fusion is preferred. This is not always available due to financial restrictions. This study explores the possibility of post implant US-CT fusion to improve contouring accuracy and potentially replace the use of MR-CT fusion.

25 participants undergoing permanent seed prostate brachytherapy will be approached to undergo collection of prostate US images at the completion of their procedure. This will add approximately 5 minutes to the duration of their brachytherapy procedure. The US study will not entail any discomfort or risk to participants as they are still under anesthesia for the implant procedure. The institution standard of care for quality assurance will be complied with, obtaining a CT and MRI of the prostate at 30 days after the procedure. These will be co-registered and analyzed in the normal fashion. In addition, the post implant US images will also be co-registered with the CT and the resulting dosimetric parameters compared.

US-CT Fusion for Post Implant Dosimetry

Comparison Between Postoperative Ultrasound-CT Fusion With MRI-CT Fusion for Postimplant Dosimetry for Prostate LDR Permanent Seed Brachytherapy

Dosimetry will be calculated using 2 different imaging modalities (US vs MRI) and compared

Assessment of prostate volume as contoured on US vs MRI post implant

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patient Satisfaction With Colonoscopy in a Danish Setting - What Are the Most Important Factors?	NCT02422680	Colorectal Canc...	No intervention...	18 Years -	Aalborg University Hospital
Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy	NCT01969292	Colon Cancer	Colometer Sham Software	18 Years - 65 Years	University of Calgary
Patient Satisfaction With Colonoscopy in a Danish Setting - What Are the Most Important Factors?	NCT02422680	Colorectal Canc...	No intervention...	18 Years -	Aalborg University Hospital
Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation	NCT05888623	Colorectal Neop...	Computer Assist...	-	VA Puget Sound Health Care System
Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy	NCT01969292	Colon Cancer	Colometer Sham Software	18 Years - 65 Years	University of Calgary
Patient Satisfaction With Colonoscopy in a Danish Setting - What Are the Most Important Factors?	NCT02422680	Colorectal Canc...	No intervention...	18 Years -	Aalborg University Hospital
US-CT Fusion for Post Implant Dosimetry	NCT03692104	Prostate Cancer	transrectal ult...	40 Years - 80 Years	British Columbia Cancer Agency
US-CT Fusion for Post Implant Dosimetry	NCT03692104	Prostate Cancer	transrectal ult...	40 Years - 80 Years	British Columbia Cancer Agency

Spots Global Cancer Trial Database for quality assurance