Background and Aims: Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy still occur. An increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device includes a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope's optics, and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing the ADR. Methods: In this randomized, controlled, international, multicenter study (11 centers), patients (aged !50 years) referred to colonoscopy for screening, surveillance, or changes in bowel habits were randomized to undergo either balloon-assisted colonoscopy by using an insufflated balloon during withdrawal or standard highdefinition colonoscopy. The primary endpoint was the ADR. Results: One thousand patients were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (standard colonoscopy n Z 396; balloon-assisted colonoscopy n Z 407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the standard colonoscopy group (28% increase; P Z .0027). Additionally, balloonassisted colonoscopy provided for a significant increase in detection of advanced (P Z .0033) flat adenomas (P < .0001) and sessile serrated adenomas/polyps (P Z .0026). Conclusion: Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat, and sessile serrated adenomas/polyps when compared with standard colonoscopy. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates and consequently reducing interval cancer incidence.
Summary
Objective
Obesity is a major public health issue with significant impact on quality of life, morbidity and mortality rates. It is estimated that if the current trends continue, 18% of men and 21% of women worldwide will be obese by 2025. All the current therapies are not optimal due to limited efficacy or safety; thus, there is a need for additional devices for the treatment of obesity. This study aimed to examine the safety, tolerability, and efficacy of a biodegradable encapsulated Epitomee device for weight loss. The technology is based on absorbent pharmaceuticals polymers and bonding materials that self‐expand in the stomach to create a pH‐sensitive super absorbent gel structure for weight loss.
Methods
A prospective, 12‐week twice daily use of the encapsulated device in patients with body mass index of 27–40 kg m
−2
. Efficacy endpoints were the percent total body weight loss (%TBWL), proportion of participants with 5% TBWL and changes in cardio‐metabolic markers. Safety analysis included evaluation of adverse events, laboratory and endoscopic findings.
Results
Overall, 52 patients completed the study. TBWL per intension‐to‐treat analysis was 3.68 ± 3.07% (3.23 ± 2.69 kg) and 4.52 ± 2.97% (3.95 ± 2.57 kg) per protocol. No device serious adverse effects reported. The most common adverse events were headache (18.1%), viral infection (11.5%), abdominal discomfort (10.1%), bloating (7.9%), nausea and constipation (5% each) and flatulence (4.3%). Endoscopy in 26 patients revealed mild, asymptomatic gastric/duodenal erythema without erosions in five patients.
Conclusions
Twelve weeks of Epitomee capsules treatment combined with lifestyle counselling resulted in 3.68–4.52% of TBWL. With continued research, the Epitomee capsules have considerable potential to become a non‐invasive, safe and effective treatment option for weight loss.
Capsule endoscopy detected more small-bowel lesions than ileocolonoscopy, and provided additional potentially relevant information on upper gastrointestinal pathology in patients with spondyloarthropathies.
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