Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of GERD

Summary: Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the safety and effectiveness of RefluxStop for the treatment of GERD.
  The used medical device "RefluxStop" is an implantable single use sterile device to ensure maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or eliminate GERD.

Detailed description: Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the safety and effectiveness of RefluxStop for the treatment of GERD.
  The used medical device "RefluxStop" is an implantable single use sterile device to ensure maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or eliminate GERD.
  The study plan will include a screening/baseline visit, a surgical procedure phase with hospital stay until discharge, and follow-up visits at 6 weeks, 3 months and 6 months after device implantation.
  The study will include a part A (20 patients followed for 6 weeks) and a part B (the first 20 patients assessed at 3 months and 6 months, and the remaining 30 patients assessed at weeks, 3 months, and 6 months).
  An independent Safety Monitoring Board (SMB) will review the results of the first 20 patients after 6 weeks.
  The Board will also meet one month prior to the anticipated inclusion of 50 patients in order to recommend whether an increase of the sample size will be needed for safety documentation purposes.

Eligibility: Inclusion Criteria:
  -  Subject's age >= 18 years and <= 75 years
  -  Subject is able to undergo general anaesthesia and is a suitable laparoscopic surgical candidate
  -  Subject is willing and able to participate
  -  Subject has provided written informed consent after being informed of the study procedure and risks prior to any study-related events
  -  Subject has documented typical GERD symptoms present for > 6 months which respond to PPIs as anti-GERD medication. Typical symptom of GERD is defined as heartburn, which is a burning epigastric or substernal pain
  -  Subject requires daily PPI anti GERD medication
  -  Subject has a 24-hour pH monitoring proven GERD performed taken off any anti reflux medication or after discontinuation for at least 7 days prior to testing. Total distal oesophageal pH must be <= 4 for >= 4.5% if time during a 24-hour monitoring
  Exclusion Criteria:
  -  Subject is currently participating in another study involving investigational drugs or devices
  -  Subject has a history of gastro oesophageal surgery, anti-reflux or bariatric procedure
  -  Subject has a history of endoscopic anti-reflux intervention
  -  Subject has a history or a suspicion of oesophageal or gastric cancer
  -  Subject has a history of major psychiatric disorder
  -  Presence of a para-oesophageal hernia or sliding hernia of > 3cm determined on endoscopy
  -  Presence of an oesophagitis grade C or D according to the Los Angeles classification
  -  Presence of oesophageal dysmotility disorder such as but not limited to sclerodermia, achalasia, Nutcracker oesophagus
  -  Presence of oesophageal stricture or stenosis
  -  Presence of delayed gastric emptying
  -  Presence of oesophageal or gastric varies
  -  Subject has a body mass index (BMI) > 35kg/m2
  -  Female patients who are pregnant or nursing
  -  Subjects who are unable to comply with the protocol requirements
  -  Subjects with limited life expectancy (< 3 years)
  -  Intra-operative findings that may preclude conduct of the study procedures

Relevance to patient case: not relevant