Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Colonic Diseases

Colonic Neoplasms

Adenoma

Colonic Polyps

Polyps

Rectal Diseases

Colorectal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. Participants will undergo blood collection and will then complete a standard-of-care screening colonoscopy.

Freenome test

Aasma Shaukat, MD MPH

Theodore R Levin, MD

Lance Baldo, MD

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this prospective multi-center observational study is to validate a blood-based test for the detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test.

Prevention of Colorectal Cancer Through Multiomics Blood Testing

Freenome Holdings Inc.

Herbal and Botanical

All Drugs and Chemicals

Cola

Cancer of the colon and rectum is second only to lung cancer as the leading cause of cancer-related deaths in the United States.Each year, about 1.23 million new cases of bowel cancer are diagnosed worldwide, 333,000 in Europe alone. Colorectal cancer almost always starts in a benign growth called a polyp. Polyps originate in the inner lining of the colon, where they may be visible in a screening test known as colonoscopy. Recent research has shown that appropriate screening and treatment can alleviate much of the suffering associated with colorectal cancer and reduce the number of deaths caused by this malignancy

colonoscopy system (PeerScope B System™)

Ian Gralnek, Prof.

The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum. The device is introduced rectally, as with any standard colonoscope when indications consistent with the need for the procedure are observed in the adult patient population.

The purpose of this prospective clinical study is to establish the usability of the PeerScope B System™ when used during standard colonoscopy procedure.

The study population is comprised of patients indicated for colonoscopy.

The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary endpoints:

1. The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope.
2. The second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, APC etc.
3. The third secondary endpoint is the procedure time.
4. The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician.
5. The fifth secondary endpoint is patient satisfactory.

Founded in 2009, PeerMedical develops colonoscopes capable of wide view angle at the press of the button. The PeerScope B System™ is an endoscopic platform that enables the physician to get a wide angle view while maintaining all of the features commonly used during Gastrointestinal (GI) procedures with very limited learning curve and in service process. The current standard devices have viewing limitations. By adding this viewing functionality, PeerMedical will potentially empower physicians to improve polyps detection and cancers within the colon.

PeerScope B System™ Clinical Protocol

a Prospective Clinical Study to Establish the Usability of the PeerScope B System™ When Used During Standard Colonoscopy Procedure

a full colonoscopy procedure is characterized by reaching an anatomical mark (cecum)at the end of the insertion phase and then the physician start the withdrawal screening phase

PeerMedical Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Colorectal Cancer Through Multiomics Blood Testing	NCT04369053	Colon Cancer Rectal Cancer Colon Neoplasm Colon Diseases Colon Lesion Colon Polyp Colorectal Canc... Polyp Adenoma Rectal Diseases Gastrointestina...	Freenome test	45 Years - 85 Years	Freenome Holdings Inc.
PeerScope B System™ Clinical Protocol	NCT01483040	Colon Cancer Colon Diseases Colon Polyps Colon Adenomas	colonoscopy sys...	18 Years - 70 Years	PeerMedical Ltd.
PeerScope B System™ Clinical Protocol	NCT01483040	Colon Cancer Colon Diseases Colon Polyps Colon Adenomas	colonoscopy sys...	18 Years - 70 Years	PeerMedical Ltd.

Spots Global Cancer Trial Database for colon diseases