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Safety and Efficacy Study of the FTRD System for Obtaining Full-thickness Intestinal Biopsies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673983
Recruitment Status : Unknown
Verified January 2016 by Region Skane.
Recruitment status was:  Not yet recruiting
First Posted : February 4, 2016
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Region Skane

Brief Summary:
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 Intervention/treatment Phase
Gastrointestinal Motility Disorders Procedure: Endoscopic full-thickness biopsy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endoscopic Full-thickness Biopsy of the Intestine
Study Start Date : February 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy

Arm Intervention/treatment
Experimental: Patients undergoing endoscopic full-thickness biopsy Procedure: Endoscopic full-thickness biopsy



Primary Outcome Measures :
  1. 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 :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with functional gastrointestinal motility disorders in which a full-thickness biopsy is needed to obtain a clinical diagnosis.

Exclusion Criteria:

  • Patients less than 18 years old and patients not giving consent to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673983


Contacts
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Contact: Fredrik Swahn, MD, PhD 0046-723886818 fredrik.swahn@skane.se

Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Henrik Thorlacius, MD, PhD Region Skane, Department of Surgery
Publications of Results:
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT02673983    
Other Study ID Numbers: EFAT-001
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Region Skane:
Intestinal
Biopsy
full thickness
endoscopic