Specialist commentator comments
Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
Four specialist commentators provided comments. One had used the NaviCam device as part of a research trial and 3 were familiar with the technology.
Specialist commentators had mixed opinions on the novelty of the NaviCam. One commentator felt it was thoroughly novel, 1 thought it was a significant modification, whereas 2 thought it a minor variation of existing technology.
The MiroCam Navi was identified as a similar technology. It uses a handheld magnetic paddle that is operator-dependent, instead of a magnetic robot. One commentator stated that the MiroCam Navi handheld magnet allows some control, but the magnet is too weak to hold the capsule stationary against peristalsis. The NaviCam's robot magnet allows more control, which they felt was a significant advance. Another commentator stated that the results with MiroCam Navi and NaviCam were similar and that both technologies need further modifications to show their usefulness before they can replace gastroscopy.
One commentator stated the NaviCam allows the operator to steer the capsule, which could expand the indication of capsule endoscopy from the small bowel to the stomach and colon. A second commentator stated the NaviCam is a variation of the PillCam, but with real-time viewing; although another commentator stated the PillCam is not designed to image the upper GI tract. A third commentator thought that it allows upper GI tract and potentially small bowel endoscopy to be done 'all in one go' for people who cannot tolerate or are unwilling to have conventional gastroscopy.
Three commentators highlighted that the NaviCam is much less invasive and better tolerated than conventional gastroscopy. One commentator thought the NaviCam could improve the investigation of dyspepsia (upper abdominal discomfort or pain, including heartburn) and anaemia, because it is a simple, well tolerated, low risk procedure. In comparison, conventional upper GI tract endoscopy is uncomfortable, unpopular with patients and carries the small risks associated with intubation and sedation. This commentator highlighted that 2% of the population per year have a gastroscopy, but malignancy is found in less than 1%. If a patient-acceptable procedure could be done in the community to select the small proportion of people who need to go to hospital for gastroscopy (often with sedation) to have biopsy or therapy, this would be a major advance. Another commentator stated this technology could be useful in screening.
One commentator highlighted that this technology may be of particular benefit to people who are older or frail.
One commentator stated that the NaviCam would allow visualisation of the whole of the small bowel, as well as the oesophagus, stomach and duodenum. This commentator also stated there was no irradiation with the NaviCam compared with barium contrast studies.
One commentator thought there was no additional benefit compared with current technology, except that diagnosis may be able to be done on the same day as doing the procedure.
Commentators thought that the NaviCam could replace standard gastroscopy as a diagnostic test, but not for therapy or biopsy, if it was shown that it was as accurate as other procedures.
One commentator thought the NaviCam could reduce costs by avoiding unnecessary biopsies and reducing the number of people with dyspepsia referred to secondary care for conventional endoscopy and biopsy. This commentator also thought the resource impact with the NaviCam could be less than standard gastroscopy as fewer trained staff are needed. One commentator stated that although there was a significant cost associated with the capsule, increasing its use could reduce costs if it replaced gastroscopy to any degree.
Two commentators stated the time needed to get images may be a limitation of the technology. One thought the NaviCam's real-time imaging may mean longer procedure times and another stated that conventional gastroscopy was quick in comparison. One commentator raised concerns that small bowel imaging may not be sufficient and a repeat endoscopy (with or without biopsy) may still be needed, however this is the case for all capsule procedures.
All commentators stated that special training would be needed to use the equipment and interpret images. One commentator highlighted that it takes between 1 and 2 years for a trainee to become competent in gastroscopy.
Two commentators stated that the NaviCam procedure could potentially be done in the community or primary care, in the same way as ultrasound scans. One commentator thought that access to a specialist endoscopy unit would still be needed for practitioner support.
Three commentators thought that evidence for the NaviCam was limited and more studies were needed to show any benefits. One commentator did not feel it was clinically valid for the NaviCam to replace gastroscopy, because the current studies do not show evidence of oesophageal and duodenal examination, and these are essential parts of routine gastroscopy examinations. Another commentator highlighted that the technology was in early development and large scale studies were needed to validate its use in the upper GI tract, and the feasibility of capsule control in the proximal small bowel. One commentator stated that more studies with the NaviCam are needed to improve visualisation of the whole upper GI tract and more randomised controlled studies are needed before it can be used for symptomatic patients.
Safety concerns with the NaviCam raised by commentators included its use in pregnancy (although the manufacturer has stated that this is a contraindication), the need for training in the event of complications (capsule inhalation or retention) and the need for pressure relieving equipment to prevent pressure sores while lying on the bed. Commentators also stated that the NaviCam may not be suitable for people with swallowing problems (including infants), GI strictures or pacemakers. One commentator raised concerns that the NaviCam procedure means the person has to drink a large amount of water, which may be a problem for some people. The person may need to change position, which may not be possible in older, frail people. Another commentator raised concerns about how the capsule would be removed if an oesophageal stricture was found.