References and Studies


High quality coupled with many years of experience

Home-Delivered

While many times before colon capsule endoscopy (CCE) has been proven to be nearly as accurate as an invasive colonoscopy, in CAREforCOLON Trial I we looked specifically at the results in a group of screening patients with a positive result and used home-delivered CCE, rather then conducting the procedure in a practice or clinic.

A patient who agreed to participate went through a standard Home-Delivered Colon Capsule Endoscopy by CorporateHealth and immediately the next day – without the need for additional cleansing – received a colonoscopy at Odense University Hospital in Nyborg. Neither the diagnostic team from CorporateHealth nor the specialists from OUH knew the outcome of the other procedure before both were completed, to avoid any bias.

After comparing the results, the patient was informed of the outcome and had an additional discussion for any follow-up if needed.

Since that trial in 2015 many thousand patients were served in clinical trials and through standard care across Europe. Our most recent work brings us all the way back to home-delivery. But this time by using telehealth instead of visiting nurses. 

Clinical Practice

CCE is approved across all of Europe, Japan, Canada, and other countries as a viable procedure for colorectal cancer screening. Until recently, its application was limited by a lack of clinical proof and the ability to cost effectively deliver a high-quality service to large populations.

The CAREforCOLON clinical trial program conducted the trials mentioned above to provide a baseline that shows how well CCE compares to traditional colonoscopy as well as CT colonography. Delivering the trial procedures as-a-service validated its applicability in clinical practice. A fourth, pivotal trial with over 2,000 patients of the national Danish bowel cancer screening program is recruiting patients since October 2021.

To conduct a robust evaluation of service delivery, in Scotland the Scottish Capsule Program – SCOTCAP, was launched as a pilot in June 2019 and transitioned into standard care in October 2020, serving 150-250 patients every month in large parts of Scotland. Here, symptomatic patients are provided with a managed CCE service that CHI delivers in collaboration with Medtronic and the NHS Scotland. 

What is Video Capsule Endoscopy? A nice animation.

From wired to wireless Prof Owen Epstein at the Royal Free Hospital in London is a renowned expert in video capsule endoscopy. As a frequent trainer he put together this little animation to explain what this innovation really is all about
(with permission from Prof Epstein)

Completed Clinical Trials

CAREforCOLON
Trial I

250 patients back-to-back capsule endoscopy vs colonoscopy

From June 2015 to May 2016 we have supported a scientific study to compare a traditional colonoscopy with Home-Delivered Colon Capsule Endoscopy. Conducted the Odense University Hospital and in collaboration with Medtronic and sundhed.dk250 patients from Funen with a positive stool test (iFOBT) received both a capsule screening as well as a traditional colonoscopy.

Various different articles were published in high-impact, peer reviewed journals discussing all details and implications of the trial.

CAREforCOLON
Trial III

From June 2016 to August 2017 another clinical trial compared CT colonography with Tele-Medical Colon Capsule Endoscopy. Just as in Trial I patients received a back-to-back treatment. This time 100 patients that had an incomplete colonoscopy and would have been scheduled for a follow-up CT colography were being invited to participate in this study.

Again under leadership of Odense University Hospital and in collaboration with Medtronic and sundhed.dk, CorporateHealth provided patient management and video analysis.

All patients had been recruited from the colonoscopy center in Nyborg, Denmark.

CAREforCOLON
Trial Booster

As part of the CAREforCOLON program, a GCP-compliant trial with 180 patients was conducted to assess the performance of different booster agents.

Besides cleansing the bowel comprehensively, the second key success criterium for a complete colon capsule endoscopy is capsule excretion. To facilitate movement of the capsule through the bowel at a speed that is neither too fast (to miss key findings) nor too slow (to have the battery run out before reaching the anal valve), a booster agent is applied to stimulate motility. To compare different agents, this trial split the patients into three cohorts that were all provided with a colon capsule endoscopy by CHI, but with different regimens of medication to take after swallowing the capsule.

Like all the other CAREforCOLON program trials, this was led by Odense University Hospital in collaboration with Medtronic and sundhed.dk, CorporateHealth provided patient management and video analysis.


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