Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02673983 |
| Other study ID # |
EFAT-001 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2016 |
| Est. completion date |
December 2017 |
Study information
| Verified date |
February 2021 |
| Source |
Region Skane |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
