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

NCT ID: NCT02673983

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-12-31

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.

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.

Conditions

Gastrointestinal Motility Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients undergoing endoscopic full-thickness biopsy

Group Type: EXPERIMENTAL

Endoscopic full-thickness biopsy

Intervention Type: PROCEDURE

Interventions

Endoscopic full-thickness biopsy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henrik Thorlacius, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skane, Department of Surgery

References

Schmidt A, Bauerfeind P, Gubler C, Damm M, Bauder M, Caca K. Endoscopic full-thickness resection in the colorectum with a novel over-the-scope device: first experience. Endoscopy. 2015 Aug;47(8):719-25. doi: 10.1055/s-0034-1391781. Epub 2015 Mar 12.

Reference Type: RESULT

PMID: 25763833 (View on PubMed)

Other Identifiers

EFAT-001

Identifier Type: -

Identifier Source: org_study_id