Clinical Trials

The purpose of this study is to review the clinical outcomes associated with use of a novel endoscopic full-thickness resection device that recently became available in the United States.

To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component >30%.

The purpose of this study is to establish a prospective, standardized data collection for the patients who undergo surgical treatment of progressive post-hemorrhagic hydrocephalus in neonates with the focus on comparing neuroendoscopic lavage (NEL) with other standard treatment options such as external ventricular drainage (EVD), ventricular access device (VAD) and ventricular subgaleal shunt (VSGS).

The purpose of this study is to evaluate the safety and effectiveness of coxial lumen apposing metal stents in patients with strictures (narrowing) within the gastrointestinal tract.

The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space. 

The purpose of this study is to determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable. To evaluate the effectiveness, safety, and durability of trans-orifice endoscopic suturing therapy for revision of bariatric procedures as well as study the safety, efficacy, and durability of preventative fixation of GI endoprosthetics.

The purpose of this study is to evaluate EUS-nCLE as an imaging biomarker and PCL fluid DNA analysis as a molecular biomarker for the management of pancreatic cystic lesions (PCLs).

The purpose of this study is to assess whether the OtoVU endoscopy system is safe, effective, and works as intended for.

The purpose of the human factors validation study is to evaluate the usability of the OtoVU system.

The purpose of the design validation study is to establish that the OtoVU system meets the intended use and to establish that the OtoVU system meets the user needs.

The aim of this pragmatic, randomized trial is to compare clinical outcomes between patients undergoing immediate endoscopic necrosectomy (direct endoscopic necrosectomy) compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for infected necrotizing pancreatitis.

Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic necrosis occurs as a consequence of severe acute pancreatitis in approximately 20% of patients. It can mature ...

The purpose of this study is to track endoscopically-placed stents and demonstrate that either suturing pattern is equivalent.

The purpose of this study is to assess the accuracy and safety of smart watches in the endoscopy suite for patients undergoing gastrointestinal endoscopic procedures with sedation.

The term wearable technology encompasses a wide spectrum of devices worn on or near a person. Market research suggests that one in five Americans are users of wearable technology with the market currently valued at over 30 billion dollars annually. These devices have the ability to record physical information, ranging from heart rate to pulse oximetry, as well as audio and video. These devices are often marketed to improve health and well-being, ...

The purpose of this study is to evaluate usability of the OtoNexus device when used in pediatric and adult patients in a clinical setting to detect middle ear effusion, and to determine if it is viral, bacterial, or mucoid.

To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.

The goal of this study is to determine the olfactory outcomes and quality of life outcomes associated with cautery upper limb vs cold knife upper limb nasal septal incision.

The purpose of this study is to describe the findings and outcomes of patient undergoing contrast-enhanced harmonic endoscopic ultrasound (CE-EUS) imaging. A registry will be created to monitor for possible procedure adverse events and to perform descriptive statistics for the patients who undergo this procedure.

The purpose of this study is to understand how to improve polyp resection of large polyps, and how to make it as effective and as safe as possible.

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

Inclusion Criteria:

• Patients with Barrett’s Esophagus (BE) or Esophageal Adenocarcinoma (EAC) that are planned for Endoscopic Submucosal Dissection (ESD) treatment.

Exclusion Criteria: 

• Patients without BE or EAC or that are not planned for ESD treatment.

The purpose of this study is determine if the metabolomic profile of nasal secretions can be used to reliably diagnose the presence or absence of sinusitis.

In this prospective feasibility study we will measure the dielectric properties of various gastrointestinal tissue types using freshly excised resection specimens. Patients undergoing gastrointestinal endoscopy and clinically indicated endoscopic resection will be approached for study participation. Immediately following resection, the specimen will be imaged using volumetric laser endomicroscopy for tissue characterization and precise localization of complex permittivity measurements. The resection specimen will then be submitted for routine histopathological assessment. Our group has previously used a similar framework for the study of various image enhancement technologies without impacting the care of our patients. In order to adequately measure the dielectric properties ...

Trudi will give us the data points to address residents and consultants skill level and areas of weakness during endoscopic sinus surgeries. (ESS)

The use of long-term enteral tube feeding has increased dramatically in the United States and worldwide. Radiologically-inserted gastrostomy (RIG) or percutaneous endoscopic gastrostomy (PEG) are the most common techniques used for long term enteral feeding. Gastrostomy-related complications are classified as major (peritonitis, abscess, bleeding requiring intervention/transfusion, bowel perforation, death) or minor (superficial infection, skin erosion, bleeding not requiring intervention, exit site leakage or tube complication [occluded, malpositioned/dislodged, damaged]). Not many studies have compared the outcomes and major and minor complications associated with RIG versus PEG. The primary objectives of this study are to assess pain as well as major and minor complications with gastrostomy-tube ...

Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endolumenally placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction. Up to 200 participants at 8 locations in the United States will participate in this study. The ESG procedure has been performed clinically for 3 years in the United States. We are completing ...

The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves ...

This study aims to assess adipose tissue-eosinophil content and adiopose tissue metabolism 3 months after endoscopic gastroplasty weight loss procedure.

The purpose of this study is to compare weight loss, improvement of comorbidities, improvement of lipid profile, blood sugar in patients undergoing endoscopic sleeve gastroplasty or intragastric balloon between patients who are in a weight loss program and those who are not.

The purpose of this study is to assess the risk for cancer spread caused by the leaking of tumor particles into the blood from the biopsy procedure endoscopic ultrasound guided fine needle aspiration.

This study will review and analyze the literature regarding endoscopic revision of Roux-en-Y gastric bypass surgery for the treatment of weight regain using the OverStitch, a minimally invasive endoscopic device. This study will also include information about patients who underwent TORe as part of their clinical evaluation and treatment for weight regain by chart review.

The primary aim of this pilot and feasibility, hypothesis-generating study therefore is to evaluate the effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham endoscopic surgery on symptoms in patients with diabetic or idiopathic gastroparesis.

Gastroparesis is a disorder of gastric function characterized by delay in gastric emptying, frequently associated with chronic nausea and vomiting, early satiety, postprandial fullness, abdominal pain, and malnutrition that may require nutritional support. There are few effective treatments available; more recently, a procedure called G-POEM (gastric peroral endoscopic myotomy) has been advocated to relieve symptoms by improving gastric emptying; however, it is not ...

The objectives of this study are to:

• • Measure the short and long-term overall and nasal-specific quality of life (QOL) impact of patients undergoing Endoscopic Endonasal Skull Base Surgery (EESBS) for pituitary and sellar lesions.
  • Determine the relative difference in QOL impact of EESBS for patients undergoing surgery for functional and nonfunctional pituitary adenomas.
  • Generate baseline data to development and validate a site-specific endoscopic-specific comprehensive QOL for EESBS.
  • Particular tumors of interest include pituitary tumors, Rathke’s cleft cysts, craniopharyngiomas, clival chordomas and chondrosarcomas.
  • Specific QOL aims focus on olfaction (sense of smell), gustation (sense of taste) and nasal function.

The purpose of this study is to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).

The purpose of this study is to use a patient monitoring application that monitors physiological data, psychosocial data, and responses to survey questions collected during a one month pre and three and six month postoperative observation period.