There are about 189 clinical studies being (or have been) conducted in Ecuador. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Bleeding from gastric varices (GV) is associated with high mortality. Injection of cyanoacrylate (CYA) using standard gastroscopes has demonstrated higher hemostasis and lower rebleeding rates compared to band ligation or sclerotherapy. Nevertheless CYA treatment is known to be associated with significant adverse events. Pulmonary embolism due to CYA injection is a serious and sometimes fatal complication of this therapy. Romero-Garcia et al. recently showed that, even these patients usually have respiratory symptom, this complication can be present in asymptomatic patients and with only CT pathological images showing it. On the other hand, risk of glue embolism, has been described to be dependent on the volume of CYA injected, being significantly greater with high volume. Other complications related to CYA injection are, hemorrhage from post injection ulcers, fever, peritonitis, needle impaction, and even death. Also the injection material can cause serious damage to the endoscope. Currently endoscopic treatments are CYA injection under direct visualization using a standard gastroscope and treatment under EUS guidance with injection of CYA, coils or both. However, to date, it is unknown whether one of these techniques is technically more feasible or causes less adverse events than the other. Treatment under EUS guidance may improve results because of precise targeting of the varix lumen or afferent feeding veins. This allows the vein to be obstructed with a small amount of CYA, less than used for the "blind" injection of GV with standard endoscopic technique and may reduce the risk of glue embolism. EUS can confirm varix obliteration by using Doppler. Also visualization of GV by using EUS is not impaired by blood or food in the stomach and thus can be performed in the setting of active hemorrhage.
Colonoscopy is considered the gold standard for colorectal polyp and cancer detection. However, even meticulous colonoscopy substantial numbers of colorectal polyps may be missed and carcinomas may not be prevented. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas, with the higher miss rates noted for smaller polyps. The lesions missing rate depends on several factors as the location on difficult areas to be evaluated with conventional colonoscopes (the proximal side of the ileocecal valve, haustral folds, flexures or rectal valves), a flat shape, a poor bowel preparation and inadequate endoscopy technique, particularly rapid colonoscope withdrawal. Using the commonly available 140º angle of view colonoscope, approximately 13% of the colonic surface is unseen. The incorporation of colonoscopes with a 170-degree wide angled could not improve adenoma detection rate. The introduction of high definition (HD) colonoscopes and visual image enhancement technologies as narrow band imaging (NBI, Olympus America, Center Valley, PA), i-SCAN™ (PENTAX of America, Montvale, NJ) and Fuji Intelligent Chromo-Endoscopy (FICE™, Fujinon Endoscopy, Wayne, NJ) have improved the lesion characterization, but several studies proved no increase in adenoma detection rates. The Third Eye Retroscope (Avantis Medical Systems, Sunnyvale, CA) is a disposable retrograde viewing device advanced via the accessory channel of a standard colonoscope. Allows retrograde views behind colonic folds and flexures simultaneously with the forward view of the colon. Although it was shown an increase in adenoma detection rate by 11%-25%, it has many disadvantages. It requires a separate processor and the device is disposable making the cost bigger. Occupies the working channel of the colonoscope which limits the ability to suction. If a polyp is seen the viewing device has to be removed in order to perform the polypectomy. The optic is not high definition and finally, the endoscopist has to get used to visualizing and processing two simultaneous video streams from the colonoscope and from the retroscope device.
This was a multicenter, randomized study to evaluate the safety, immunogenicity, and efficacy of VRC-ZKADNA090-00-VP (Zika virus wildtype DNA vaccine) or placebo. In Part A, the primary objective was to evaluate the safety and tolerability of the vaccine in different vaccination regimens. In Part B, the primary objectives were to evaluate the safety and efficacy of the vaccine compared to placebo.
Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.
Chronic esophageal disorders affect approximately one third part of global population, with a deleterious impact in the quality of life of patients. Measured of health related quality of life in chronic esophageal conditions such as gastroesophageal reflux disease and achalasia are widely used to measure this important patient-reported outcome. The Northwestern Esophageal Quality of Life (NEQOL) is a hybrid measure of esophageal illness, allowing for broad use across esophageal diseases while maintain sensitivity to nuances of a specific condition. The NEQOL is a reliable and valid hybrid measure of disease specific health related quality of life across several chronic esophageal conditions. The Ecuadorian Institute of Digestive Diseases aims to translate and validate this survey into Spanish for its use in a Hispanic population. This cross-sectional study aims to translate, apply and validate the NEQOL in the patients attending in the esophageal division of the institute.
Endoscopic retrograde cholangio-pancreatography (ERCP) is a diagnostic and therapeutic procedure, however it has an important image limitation. The fluoroscopic cholangiography shows the biliary tree in a two-dimensional view. When an indeterminate biliary stricture is seen, the certainly diagnosis by ERCP depends on a blind biopsy sampling with the risk of missed pathology and sampling errors. SpyGlass® System (Boston Scientific, Marlborough, Massachusetts, USA) is a cholangioscope that enables single-operator, direct visualization of the pancreatico-biliary system and the evaluation of intraductal lesions. It has a digital sensor with 4x resolution and a 1.2 mm working channel that allows the passage of the SpyBite® Forceps biopsy. It has been demonstrated that the use of SpyGlass® System and SpyBite® Forceps changes clinical management in 64% of patients. It has a sensitivity of 76.5% for indeterminate stricture diagnosis, compared to 29.4% and 5.9% sensitivity using blind biopsy brushing catheter respectively. Although it has been described before cholangioscopic images of malignant biliary lesions like an irregular lesion surface with irregular vessels and bleeding or a smooth surface without vessels for benign lesions, there is no current validated classification that allows unify the diagnostic criteria. Methods: Study design: The study was design to be performed in 2 stages. Stage 1: observational, retrospective study with case collection from September 2013 to September 2015. Patients included had bile duct tissular lesion detected by POCS. The images were correlated to histopathology and 6 month follows up and a classification was finally performed to differentiate benign forma malignant bile duct lesions. Stage 2: patients with bile duct tissular lesion detected by POCS, will be the evaluated in a prospective, non-randomized and double blind manner. Two groups of endoscopist will evaluate the images but only one group will do it using the classification previously performed. Second stage case collection has already started (December 2015) and will include patients until December 2016. - Endpoint Classification: Efficacy - Intervention Model: Non interventional - Primary Purpose: Diagnosis
This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety, tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074 5% Gel for up to 16 weeks in condyloma patients
Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders. It has prevalence in general population of 5-20% and is more common in women and young adults. Despite being one of the most frequent reasons for consultation many patients are undiagnosed. There are no reliable biomarkers. The diagnosis is clinical, based on the Rome III criteria. IBS is characterized by chronic or recurrent abdominal pain associated with changes in bowel frequency and consistency, when other etiologies are excluded. The combination of the Rome III criteria with the absence of alarm symptoms have a sensitivity of 65%, specificity of 100%, 100% positive predictive value and negative predictive value of 76%. Current tests commonly fail to obtain an objective diagnosis, and effective therapies are lacking. There are no specific endoscopic findings that can discriminate IBS patients from healthy patients. Most colonoscopies are performed to rule out other etiologies and in more than 50% of the cases are normal.
Endoscopy is a tool that has greatly influenced gastroenterological diagnosis. However, conventional endoscopy is limited to detecting lesions on the basis of gross morphological changes and therefore a certainly diagnosis depends on biopsy sampling of macroscopically obvious endoscopic features, or blind biopsy sampling of normal appearing mucosa with the risk of missed pathology and sampling errors. Gastric cancer is the second most common cause of cancer related death. One of the main roles of upper gastrointestinal endoscopy is to identify gastric cancer at an early stage. The importance of identifying H. pylori infection is because it plays a very important role in gastric carcinogenesis, progressing from chronic gastritis through atrophic gastritis, intestinal metaplasia, dysplasia and finally cancer. The importance of recognition a precancerous gastric lesion is because we can detect most tumors at an early stage and improve the survival. Most studies conclude that it is difficult to diagnose H. pylori related gastritis and gastric atrophy on the basis of endoscopic findings. Histology is therefore currently considered to be the gold standard for detecting H. pylori infection. The reliability of detecting H. pylori infection histologically depends on the site, number, and size of gastric biopsy specimens, as well as on expertise in staining and visualizing the bacteria. Considerable error also occurs in identifying gastric atrophy using blind biopsy sampling, and neither the original nor the revised version of the Sydney system reliably identifies more than half the cases in patients with confirmed gastric atrophy.
To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic breast cancer