Disorder of Small IntestineENMSETNCT02965209
European Novel Motorized Spiral Endoscopy Trial
A study testing motorized spiral enteroscopy in people with Disorder of Small Intestine and Gastrointestinal Hemorrhage, run by Evangelisches Krankenhaus Düsseldorf at 2 sites in 2 countries.
Trial summary
The subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorder of Small Intestine, Gastrointestinal Hemorrhage, Iron Deficiency Anaemia
- What is being tested?
- motorized spiral enteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2015to 6 Feb 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive videocapsule endoscopy (VCE) or negative VCE in patients who have ongoing bleeding shown by overt bleeding or continued need for blood transfusions
- Abdominal pain or chronic diarrhoea with positive findings of small bowel imaging examinations
- Noncontributory ileocolonoscopy and suspicion of Crohn's disease on small-bowel cross-sectional imaging modalities or small-bowel capsule endoscopy
- Further evaluation of known Crohn's disease or therapeutic indications in Crohn's disease
- Imaging tests suspicious for small-bowel tumour
- Large polyps (>10-15mm) discovered by radiological examination or small-bowel capsule endoscopy in patients with Peutz-Jeghers syndrome
- Nonresponsive or refractory coeliac disease
Who cannot join
- Age under 18 years
- Health status American Society of Anesthesiologists classification (ASA) 4
- Pregnancy
- Coagulopathy (INR≥2.0, Platelets < 70/nl)
- Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
- Any medical contraindication to standard enteroscopy
Show all 16Show fewer
- Presence of any intraluminal or extraluminal foreign body in the abdominal cavity
- Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable)
- Known or suspected bowel obstruction or stenosis or history of bowel obstruction
- Known coagulation disorder
- Known or suspected esophageal stricture or Schatzki ring
- Known gastric or esophageal varices
- Suspected perforation of the GI tract
- Inability to tolerate sedation or general anesthesia for any reason
- Inability to tolerate endotracheal intubation
- Absence of a signed informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. The system is similar to other currently marketed endoscopes in that it incorporates a flexible insertion tube, light source, digital imaging, and channels for passing accessories for sample collection or therapeutic interventions. The NMSE system is unique in that it incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft spiral-shaped "fins", pleats the small bowel on to the endoscope's insertion tube, thereby allowing rapid and atraumatic access deep into the small bowel. The system also includes a display monitor, a motor control unit, device to display measured motor current and signal torque, and a set of foot pedals. Motorization of the Spiral Enteroscope and limitation of rotation to a short cuff instead of a long overtube promise to accelerate the procedure, to facilitate insertion and to improve maneuvering the instrument in comparison to conventional spiral enteroscopy
Read the detailed description
General anesthesia and/or sedation will be prescribed according to institutional practices and clinical judgment; type, amount and duration will be recorded.
A standard esophagogastroduodenoscopy (EGD) will be performed prior to the enteroscopy. If during this preliminary exam the endoscopist identifies any stricture or believes the patient has anatomy that would cause excessive resistance during Novel Motorized Spiral insertion or examination, the patient will be withdrawn from the study and the reason for study withdrawal will be noted.
The Novel Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, (controlled directly by the operating physician via the foot pedal). If at any point a stricture is observed or excessive resistance to the advancement of the endoscope is encountered, further advancement of the endoscope must cease and the reason for procedure termination documented on the case report form.
After reaching the depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal. Maximum depth of insertion will be recorded as the maximum insertion depth when failure to advance the endoscope tip after repositioning the patient, applying abdominal pressure and/or using other standard measures fails to advance the endoscope OR the investigator decides to terminate advancement based on clinical judgment. During withdrawal, the endoscopist will cumulatively estimate the length of bowel released from the endoscope tip in order to calculate the total depth of insertion. Insertion depth will be referenced to the Ligament Treitz. If the clinician decides to mark the point of maximum insertion, the tissue may be tattooed by first creating a saline bleb, followed by the injection of India ink (e.g., SPOT).
Tissue sampling and/or therapies will be performed during withdrawal as clinically appropriate. The details of all sampling and/or therapies (number, type \& location) will be recorded.
The comfort and cardiopulmonary stability of the patient will be monitored throughout the procedure, as per the standard of care - this includes continuous pulse oximetry, blood pressure, and heart rate monitoring.
Photographs or video recordings are used to document any significant lesions and any tissue trauma.
Postprocedural measures Patients will be hospitalized for at least 24 hours after NMSE because of the potential risk of delayed adverse events. Only liquid diet is allowed during the first 12 hours in asymptomatic patients. Clinical investigation and determination of the blood cell count and the serum level of C-reactive protein will be done after 24 hours. 30 days after the procedure patients will be interviewed by a telephone call for evaluation of complaints or delayed complications. Discomfort (location and severity (0-10 VAS) should be documented immediately after NMSE, after 24 hours and before discharge.
- Conditions
- Disorder of Small Intestine, Gastrointestinal Hemorrhage, Iron Deficiency Anaemia, Crohn's Disease, Small Bowel Tumors, Intestinal Polyposis Syndrome
- Being tested
- motorized spiral enteroscopy
- Keywords
- endoscopy, small bowel endoscopy, motorized spiral endoscopy, spiral endoscopy
- Medical subject headings
- Gastrointestinal Hemorrhage, Anemia, Iron-Deficiency, Crohn Disease, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motorized spiral enteroscopyProcedure or surgery
Also called standard endoscopic interventions (not experimental)
Novel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. When the region of interest in the small bowel is reached by NMSE standard endoscopic techniques, e.g. argon plasma coagulation (APC), forceps biopsy or endoscopic mucosal resection (EMR) are performed for treatment and/or tissue acquisition.
| Study group | Role | What they receive |
|---|---|---|
| motorized spiral enteroscopy | Experimental | Novel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. Receives: Procedure: motorized spiral enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of NMSE in patients with suspected small bowel diseases
Measured: 30 days
Secondary outcomes (5)
Procedural success
Measured: 30 days
Procedural time (minutes)
Measured: 30 days
Depth of maximal insertion (cm)
Measured: 30 days
Therapeutic yield
Measured: 30 days
Adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2015
- Primary completion3 Feb 2018
- Study completion6 Feb 2018
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 Disorder of Small IntestineStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelisches Krankenhaus Düsseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Principal investigator, Torsten Beyna, Evangelisches Krankenhaus Düsseldorf
- Investigators
- Horst Neuhaus, MD, Principal investigator, Evangelisches Krankenhaus Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965209
- Sponsor's protocol ID
- ENMSET
- Acronym
- ENMSET
- Status last verified
- Feb 2018
- First submitted
- 11 Nov 2016
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Beyna T, Arvanitakis M, Schneider M, Gerges C, Boing D, Deviere J, Neuhaus H. Motorised spiral enteroscopy: first prospective clinical feasibility study. Gut. 2021 Feb;70(2):261-267. doi: 10.1136/gutjnl-2019-319908. Epub 2020 Apr 24.
PubMed 32332141
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Novel Motorized Spiral Endoscopy Trial
- ClinicalTrials.gov ID
- NCT02965209
- Acronym / sponsor ID
- ENMSET / ENMSET
- Conditions
- Disorder of Small Intestine, Gastrointestinal Hemorrhage, Iron Deficiency Anaemia, Crohn's Disease, Small Bowel Tumors, Intestinal Polyposis Syndrome
- Keywords
- endoscopy, small bowel endoscopy, motorized spiral endoscopy, spiral endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Evangelisches Krankenhaus DüsseldorfUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- Nov 2015
- Primary completion
- 3 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 16 Nov 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 subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. The system is similar to other currently marketed endoscopes in that it incorporates a flexible insertion tube, light source, digital imaging, and channels for passing accessories for sample collection or therapeutic interventions. The NMSE system is unique in that it incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft spiral-shaped "fins", pleats the small bowel on to the endoscope's insertion tube, thereby allowing rapid and atraumatic access deep into the small bowel. The system also includes a display monitor, a motor control unit, device to display measured motor current and signal torque, and a set of foot pedals. Motorization of the Spiral Enteroscope and limitation of rotation to a short cuff instead of a long overtube promise to accelerate the procedure, to facilitate insertion and to improve maneuvering the instrument in comparison to conventional spiral enteroscopy
Detailed description
General anesthesia and/or sedation will be prescribed according to institutional practices and clinical judgment; type, amount and duration will be recorded.
A standard esophagogastroduodenoscopy (EGD) will be performed prior to the enteroscopy. If during this preliminary exam the endoscopist identifies any stricture or believes the patient has anatomy that would cause excessive resistance during Novel Motorized Spiral insertion or examination, the patient will be withdrawn from the study and the reason for study withdrawal will be noted.
The Novel Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, (controlled directly by the operating physician via the foot pedal). If at any point a stricture is observed or excessive resistance to the advancement of the endoscope is encountered, further advancement of the endoscope must cease and the reason for procedure termination documented on the case report form.
After reaching the depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal. Maximum depth of insertion will be recorded as the maximum insertion depth when failure to advance the endoscope tip after repositioning the patient, applying abdominal pressure and/or using other standard measures fails to advance the endoscope OR the investigator decides to terminate advancement based on clinical judgment. During withdrawal, the endoscopist will cumulatively estimate the length of bowel released from the endoscope tip in order to calculate the total depth of insertion. Insertion depth will be referenced to the Ligament Treitz. If the clinician decides to mark the point of maximum insertion, the tissue may be tattooed by first creating a saline bleb, followed by the injection of India ink (e.g., SPOT).
Tissue sampling and/or therapies will be performed during withdrawal as clinically appropriate. The details of all sampling and/or therapies (number, type \& location) will be recorded.
The comfort and cardiopulmonary stability of the patient will be monitored throughout the procedure, as per the standard of care - this includes continuous pulse oximetry, blood pressure, and heart rate monitoring.
Photographs or video recordings are used to document any significant lesions and any tissue trauma.
Postprocedural measures Patients will be hospitalized for at least 24 hours after NMSE because of the potential risk of delayed adverse events. Only liquid diet is allowed during the first 12 hours in asymptomatic patients. Clinical investigation and determination of the blood cell count and the serum level of C-reactive protein will be done after 24 hours. 30 days after the procedure patients will be interviewed by a telephone call for evaluation of complaints or delayed complications. Discomfort (location and severity (0-10 VAS) should be documented immediately after NMSE, after 24 hours and before discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| motorized spiral enteroscopy | Experimental | Procedure: motorized spiral enteroscopyNovel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive videocapsule endoscopy (VCE) or negative VCE in patients who have ongoing bleeding shown by overt bleeding or continued need for blood transfusions
- Abdominal pain or chronic diarrhoea with positive findings of small bowel imaging examinations
- Noncontributory ileocolonoscopy and suspicion of Crohn's disease on small-bowel cross-sectional imaging modalities or small-bowel capsule endoscopy
- Further evaluation of known Crohn's disease or therapeutic indications in Crohn's disease
- Imaging tests suspicious for small-bowel tumour
Key exclusion criteria (16 listed)
- Age under 18 years
- Health status American Society of Anesthesiologists classification (ASA) 4
- Pregnancy
- Coagulopathy (INR≥2.0, Platelets < 70/nl)
- Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
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 |
|---|---|---|
| motorized spiral enteroscopyAlso: standard endoscopic interventions (not experimental)Novel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. When the region of interest in the small bowel is reached by NMSE standard endoscopic techniques, e.g. argon plasma coagulation (APC), forceps biopsy or endoscopic mucosal resection (EMR) are performed for treatment and/or tissue acquisition. | Procedure or surgery | motorized spiral enteroscopy |
Primary outcome
Diagnostic yield of NMSE in patients with suspected small bowel diseases
Time frame: 30 days
5 secondary outcomes
Procedural success
Time frame: 30 days
Procedural time (minutes)
Time frame: 30 days
Depth of maximal insertion (cm)
Time frame: 30 days
Therapeutic yield
Time frame: 30 days
Adverse events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Derived from this study: PubMed 32332141Beyna T, Arvanitakis M, Schneider M, Gerges C, Boing D, Deviere J, Neuhaus H. Motorised spiral enteroscopy: first prospective clinical feasibility study. Gut. 2021 Feb;70(2):261-267. doi: 10.1136/gutjnl-2019-319908. Epub 2020 Apr 24.
- Individual participant dataSharing planned: Undecided
Related trials for Disorder of Small Intestine
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 1/2
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Advanced Solid Tumors, Metastatic Solid Tumors
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.
Horst Neuhaus, MD principal investigator
Evangelisches Krankenhaus Duesseldorf
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motorized spiral enteroscopy in people with Disorder of Small Intestine and Gastrointestinal Hemorrhage, run by Evangelisches Krankenhaus Düsseldorf at 2 sites in 2 countries.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic yield of NMSE in patients with suspected small bowel diseases (time frame: 30 days). 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 NCT02965209, 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 14 Feb 2018.