Safety and Efficacy Study of the FTRD System for Obtaining Full-thickness Intestinal Biopsies
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ClinicalTrials.gov Identifier: NCT02673983
Recruitment Status : Unknown
Verified January 2016 by Region Skane. Recruitment status was: Not yet recruiting
The aim of this study is to evaluate FTRD (full-thickness resection device) in terms of obtaining full-thickness biopsies form the gastrointestinal tract endoscopically in the work-up of patients with gastrointestinal motility disorders.
Condition or disease
Gastrointestinal Motility Disorders
Procedure: Endoscopic full-thickness biopsy
Functional intestinal disorders are a common problem and diagnosis is a challenge to clinicians. Several motility disorders are caused by pathological changes in the neuromuscular network in the intestinal wall. To obtain a diagnosis a full-thickness biopsy is required. At present, this kind of biopsy is usually obtained by a laparoscopic surgical procedure, requiring full anesthesia, operating room and several days of postoperative care in the hospital. Today, there is lacking a more minimal invasive approach for obtaining full-thickness biopsies from the gastrointestinal tract. A new device has been developed called full-thickness resection device (FTRD), which has proved useful and safe from removing polyps in the gastrointestinal tract (Schmidt A Endoscopy 47;8, 719-725). The specific aims of this study is to determine if FTRD safe for obtaining full-thickness biopsies form the gastrointestinal tract and whether these FTRD biopsies be used for clinical diagnosis of patients with suspected intestinal motility disorders. If these aims can be achieved FTRD would be of potential great value for patients and health care in the management of patients with gastrointestinal disorders. 40 patients will be included, i.e. 10 patients will undergo FTRD biopsy in the sigmoid colon, distal ileum, jejunum and duodenum. Patients will undergo the biopsy procedure under conscious sedation at the Endoscopy Unit in Malmö, Region Skane and stay one night at the hospital to detect any complications. A venous blood sample will be taken before and 24 hours after the biopsy for examination of systemic inflammatory changes. All biopsies will examined by an expert in neuromuscular pathology.
Safety: The number of patients with bleeding or perforation will be determined and reported. [ Time Frame: 24 hours ]
Upon signs of clinical significant bleeding a colonoscopy will be performed and upon clinical signs of perforation will the patient undergo a computer tomography. The number of patients with bleeding or perforation will be determined and reported.
Secondary Outcome Measures :
Efficacy: The number of patients in which a clinical diagnosis was obtained based on the full thickness biopsy will be determined and reported. [ Time Frame: 4-8 weeks when pathological examination is completed ]
The number of patients in which a clinical diagnosis was obtained based on the full thickness biopsy will be determined and reported.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with functional gastrointestinal motility disorders in which a full-thickness biopsy is needed to obtain a clinical diagnosis.
Patients less than 18 years old and patients not giving consent to participate