Gastrointestinal Motility DisordersNCT02673983
Safety and Efficacy Study of the FTRD System for Obtaining Full-thickness Intestinal Biopsies
A study testing Endoscopic full-thickness biopsy in people with Gastrointestinal Motility Disorders, run by Region Skane.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Motility Disorders
- What is being tested?
- Endoscopic full-thickness biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with functional gastrointestinal motility disorders in which a full-thickness biopsy is needed to obtain a clinical diagnosis.
Who cannot join
- Patients less than 18 years old and patients not giving consent to participate
About this study
Official title: Endoscopic Full-thickness Biopsy of the Intestine
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.
Read the 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
- Being tested
- Endoscopic full-thickness biopsy
- Keywords
- Intestinal, Biopsy, full thickness, endoscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic full-thickness biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing endoscopic full-thickness biopsy | Experimental | Not described Receives: Procedure: Endoscopic full-thickness biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: The number of patients with bleeding or perforation will be determined and reported.
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.
Measured: 24 hours
Secondary outcomes (1)
Efficacy: The number of patients in which a clinical diagnosis was obtained based on the full thickness biopsy will be determined and reported.
The number of patients in which a clinical diagnosis was obtained based on the full thickness biopsy will be determined and reported.
Measured: 4-8 weeks when pathological examination is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: The study was never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Motility DisordersStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik Thorlacius, MD, PhD, Principal investigator, Region Skane, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673983
- Sponsor's protocol ID
- EFAT-001
- Status last verified
- Feb 2021
- First submitted
- 15 Jan 2016
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25763833
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full-thickness Biopsy of the Intestine
- ClinicalTrials.gov ID
- NCT02673983
- Acronym / sponsor ID
- EFAT-001
- Conditions
- Gastrointestinal Motility Disorders
- Keywords
- Intestinal, Biopsy, full thickness, endoscopic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing endoscopic full-thickness biopsy | Experimental | Procedure: Endoscopic full-thickness biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with functional gastrointestinal motility disorders in which a full-thickness biopsy is needed to obtain a clinical diagnosis.
Key exclusion criteria (1 listed)
- Patients less than 18 years old and patients not giving consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic full-thickness biopsy | Procedure or surgery | Patients undergoing endoscopic full-thickness biopsy |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Results publication: PubMed 25763833Schmidt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Thorlacius, MD, PhD principal investigator
Region Skane, Department of Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic full-thickness biopsy in people with Gastrointestinal Motility Disorders, run by Region Skane.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: The number of patients with bleeding or perforation will be determined and reported. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02673983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.