NL-OMON35914撤回不适用
Open prospective study to evaluate the safety and preliminary effectiveness of the BaroSense ACE(TM) Stapler for plication of dilated post-surgical gastric anatomy - Gastric Pouch Revisions with BaroSense Stapler
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Subject, male or female, is age 18 to 60 years of age.
- •2.Subject must be able to understand and be willing to sign an informed consent document.
- •3.Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
- •4.Subject must be > 2 years post RYGB surgery.
- •5.Subject must have documented records indicating an initial achievement of > 60% EWL (based on an ideal weight of 25 BMI) at some point after RYGB surgery.
- •6.Subject has a BMI at baseline of > 30 and < 50. (for this protocol)
- •7.At time of enrollment, subject must have regained at least 35% of the maximum weight lost following RYGB, and the weight regain must have occurred over a period of not less than 3 months from the point of maximum weight loss.
- •8.Subject must have a stoma diameter of at least 18 mm (at the site the jejunum attaches to the pouch).
- •9.Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
- •10.Subject can undergo general anesthesia, as evaluated by the Principal Investigator.
- •11.Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator.
- •12.Subject*s general practitioner will be informed about the subject*s participation in this study. 13.Subject agrees to refrain from any type of reconstructive surgery that may affect body weight such as mammoplasty or abdominal lipoplasty or liposuction, during the trial.
- •14.Subject agrees to follow the post procedure aftercare program.
排除标准
- •1.Subject has a severe eating disorder.
- •2.Investigator determines that there is another causal factor for the subject*s weight regain other than dilated gastric anatomy.
- •3.Subject has previously undergone an endoscopic or surgical repair of dilated pouch or stoma (including sclerotherapy treatments).
- •4.Subject had irreversible or life threatening complications following initial RYGB procedure (cardio or respiratory).
- •5.Subject has an ongoing severe complication from their initial RYGB procedure (recurrent ventral hernia, pain syndrome, etc.).
- •6.Subject has an intragastric fistula, anastomotic leak, or staple/suture line disruption.
- •7.Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
- •8.Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- •9.Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
- •10.Subject has significant esophageal disease including Zenker*s diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett*s esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility.
- •11.Subject has renal and/or hepatic insufficiency.
- •12.Subject has thyroid disease which is not controlled with medication.
- •13.Subject has a history of intestinal strictures or adhesions.
- •14.Subject has systemic infection in the body at the time of procedure.
- •15.Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to the procedure), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
- •16.Female subject who started birth control pills less than 3 months before enrollment, or who plans to start taking birth control pills during the study
- •17.Subject has had previous esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis.
- •18.Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation.
- •19.Subject is observed at baseline EGD to have malignant or poor quality/friable tissue in areas where the plications are likely to be placed.
- •20.Subjects who are unable to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to a procedure and continuing for 14 days post-procedure.
- •21.Subjects undergoing chronic steroid therapy.
- •22.Subjects undergoing immunosuppressive therapy.
- •23.Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the procedure as well as during the trial period.
- •24.Subjects who have cardiac pacemakers or other electronic implantable devices.
- •25.Subjects who have hiatal hernias greater than 2 cm.
- •26.Subjects who have current or potential neck masses that in the opinion of the investigator, may interfere with study-related procedures, or who have a Mallampati (intubation) score greater than 3.
- •27.Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or
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