Weight Management Center, Nuova Villa Claudia Clinic, Rome, Italy.
General Surgery Department, Jarallah German Clinic, Kuwait City, Kuwait.
Obes Surg. 2020 Sep;30(9):3354-3362. doi: 10.1007/s11695-020-04539-8.
The Elipse balloon is a novel, non-endoscopic option for weight loss. It is swallowed and filled with fluid. After 4 months, the balloon self-empties and is excreted naturally. Aim of the study was to evaluate safety and efficacy of Elipse balloon in a large, multicenter, population.
Data from 1770 consecutive Elipse balloon patients was analyzed. Data included weight loss, metabolic parameters, ease of placement, device performance, and complications.
Baseline patient characteristics were mean age 38.8 ± 12, mean weight 94.6 ± 18.9 kg, and mean BMI 34.4 ± 5.3 kg/m. Triglycerides were 145.1 ± 62.8 mg/dL, LDL cholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was 5.1 ± 1.1%. Four-month results were WL 13.5 ± 5.8 kg, %EWL 67.0 ± 64.1, BMI reduction 4.9 ± 2.0, and %TBWL 14.2 ± 5.0. All metabolic parameters improved. 99.9% of patients were able to swallow the device with 35.9% requiring stylet assistance. Eleven (0.6%) empty balloons were vomited after residence. Fifty-two (2.9%) patients had intolerance requiring balloon removal. Eleven (0.6%) balloons deflated early. There were three small bowel obstructions requiring laparoscopic surgery. All three occurred in 2016 from an earlier design of the balloon. Four (0.02%) spontaneous hyperinflations occurred. There was one (0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outlet obstruction, delayed intestinal balloon transit, and gastric perforation (repaired laparoscopically).
The Elipse™ Balloon demonstrated an excellent safety profile. The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement across all metabolic parameters.
Elipse 球囊是一种新型的非内镜减肥选择。它被吞咽并充满液体。4 个月后，球囊会自动排空并自然排出。本研究的目的是评估 Elipse 球囊在大型多中心人群中的安全性和疗效。
对 1770 例连续 Elipse 球囊患者的数据进行了分析。数据包括体重减轻、代谢参数、放置的难易程度、设备性能和并发症。
患者的基线特征为平均年龄 38.8±12 岁，平均体重 94.6±18.9kg，平均 BMI 34.4±5.3kg/m2。甘油三酯为 145.1±62.8mg/dL，LDL 胆固醇为 133.1±48.1mg/dL，HbA1c 为 5.1±1.1%。4 个月的结果为 WL 13.5±5.8kg，%EWL 67.0±64.1，BMI 减少 4.9±2.0，%TBWL 14.2±5.0。所有代谢参数均有所改善。99.9%的患者能够吞下该设备，其中 35.9%需要使用引导丝。11 例（0.6%）排空后的球囊被呕吐。52 例（2.9%）因不耐受需要取出球囊。11 例（0.6%）球囊早期瘪缩。有 3 例小肠梗阻需要腹腔镜手术。这 3 例均发生在 2016 年，源于球囊的早期设计。有 4 例（0.02%）自发性球囊过度膨胀。有 1 例（0.06%）各发生食管炎、胰腺炎、胃扩张、胃出口梗阻、肠内球囊传输延迟和胃穿孔（腹腔镜修补）。
ElipseTM 球囊表现出极佳的安全性。该球囊还具有显著的疗效，TBWL 达到 14.2%，所有代谢参数均有所改善。
