Neoplasms

All Conditions

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Motorized Spiral Colonoscopy (MSC) with the novel motorized spiral endoscope represents a new technology which offers all of the advantageous options of spiral-assisted endoscopy with a faster and less invasive approach

For any pathological finding during colonoscopy standard endoscopic techniques, e.g. forceps biopsy, injection, endoscopic mucosal resection, argon plasma coagulation

Motorized Spiral Colonoscopy

Horst Neuhaus, MD, PhD

The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation rate of at least 90 % according to quality guidelines recommendations. All other clinically relevant quality parameters of standard colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study represents the first clinical evaluation of using a motorized spiral assisted endoscope for examination of the colon with potential advantages for patients in terms of effectiveness and convenience of colonoscopy.

Colonoscopy has been widely accepted for the diagnosis and treatment of colon diseases. Properly performed, colonoscopy is generally safe, accurate, and well-tolerated. Diagnostic colonoscopy is the preferred method to evaluate the colon in most patients with large-bowel symptoms, iron deficiency anemia, abnormal results on radiographic studies of the colon, positive results on colorectal cancer (CRC) screening tests, post-polypectomy and post-cancer resection surveillance, and diagnosis and surveillance in inflammatory bowel disease. In addition, colonoscopy has been introduced for CRC screening in some Western countries e.g. in the United States and Germany. Recent trials showed that screening colonoscopy has a large potential for prevention and early detection of colorectal cancer. Diagnostic colonoscopy is usually combined with endoscopic resection of small and medium sized polyps and flat neoplastic lesions. Patients in whom larger lesions are detected at a diagnostic colonoscopy are usually rescheduled for therapeutic colonoscopy in an appropriate setting.

Quality parameters for colonoscopy were recently reported. In terms of intraprocedural indicators a cecal intubation rate of ≥ 90% for all cases of colonoscopy is widely accepted. Even experienced endoscopists classify up to 10% of colonoscopies as difficult and intubation of the cecum may then be impossible. A recent study evaluated the efficacy and safety of repeating colonoscopy in 520 patients with prior incomplete colonoscopy. Reasons for failure to complete colonoscopy in referring institutions were "looping/redundant colon" in 53.8% of the cases, "sigmoid fixation/angulation" in 38.8%, "both sigmoid angulation and looping colon" in 5.8% of the cases. Issues with sedation caused failures in 1.5% of the patients. Conventional colonoscopy can be difficult in particular in these anatomical variations because pushing the endoscope tends to form loops with limited or no advancement of the tip of the instrument. Techniques like alternating pushing and pulling the endoscope or external compression of the abdomen are used to overcome these limitations. Loop formation and stretching the colon with the adjacent mesenterium as well as external compression are inconvenient or even painful for the patient. In addition these maneuvers prolong the procedural duration. We recently compared the use of ultrathin colonoscopies with standard colonoscope in a randomized trial in terms of cecal intubation rate, level of sedation, amount of propofol needed for sedation, number of external compressions, pain score patient satisfaction and other parameters. The results indicate that these parameters can be well used for evaluation of a new technique of colonoscopy.

Spiral assisted endoscopy is based on a completely different concept of advancing an endoscope by pleating of bowel on the instrumentation shaft by rotation. This technique has been widely used for antegrade enteroscopy. For this purpose a manually rotatable overtube is used through which a thin flexible enteroscope is inserted. The distal end of the overtube contains a raised spiral thread for pleating the small intestine over the overtube. By manually rotating the spiral element the bowel pleats onto the overtube, allowing the operator to access and visualize the more distal portions of the small intestine. Spiral assisted endoscopy has been also approved and evaluated for retrograde enteroscopy via the anal route. It promises advantage for intubation of the cecum and the terminal ileum by its principle of pleating at least parts of the colon with consecutive shortening and less loop formation. These effects should reduce the need for external compression and they may cause less pain for patients. In addition, the spiral should stabilize the position of the colonoscope which is advantageous for careful examination and targeted interventions. Spiral overtube-assisted colonoscopy achieved a success rate of cecal intubation in 92% of 24 patients in whom conventional colonoscopy had failed. However conventional spiral endoscopy is cumbersome to use and requires assistance by a second endoscopist for its appropriate use.

The Novel Motorized Spiral Endoscope represents a new technology which offers all of the advantageous options of spiral-assisted endoscopy 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 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 colon on to the endoscope's insertion tube, thereby allowing rapid and atraumatic access into the colon. 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. It is currently being evaluated in a prospective study in patients with indications for antegrade enteroscopy ("European Novel Motorized Spiral Endoscopy Trial (ENMSET)) in the two centers conducting this study. So far more than 60 patients were successfully examined without major adverse events.

The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation rate of at least 90 % according to quality guidelines recommendations. All other clinically relevant quality parameters of standard colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study represents the first clinical evaluation of using a motorized spiral assisted endoscope for examination of the colon with potential advantages for patients in terms of effectiveness and convenience of colonoscopy.

Motorized Spiral Colonoscopy Trial: A First Feasibility Trial

Motorized Spiral Colonoscopy Trial (MSCT): A First Feasibility Trial

external compression necessary during intervention, yes/no?

sedation depth assessed by ESGE-guideline, level 1-3

Olympus

Evangelisches Krankenhaus Düsseldorf

Symptoms and General Pathology

Digestive System Diseases

Blood and Lymph Conditions

Nutritional and Metabolic Diseases

Rare Diseases

Syndrome

Hemorrhage

Crohn Disease

Anemia

Anemia, Iron-Deficiency

Iron Deficiencies

Gastrointestinal Hemorrhage

Celiac Disease

Intestinal Polyposis

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Gastrointestinal Diseases

Metabolic Diseases

Iron Metabolism Disorders

Anemia, Hypochromic

Hematologic Diseases

Malabsorption Syndromes

Small Intestine Cancer

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.

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.

motorized spiral enteroscopy

Horst Neuhaus, MD

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

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Motorized Spiral Colonoscopy Trial: A First Feasibility Trial	NCT03000361	Colonoscopy Safety Issues Adenoma	Motorized Spira...	18 Years -	Evangelisches Krankenhaus Düsseldorf
European Novel Motorized Spiral Endoscopy Trial	NCT02965209	Disorder of Sma... Gastrointestina... Iron Deficiency... Crohn's Disease Small Bowel Tum... Intestinal Poly... Coeliac Disease	motorized spira...	18 Years -	Evangelisches Krankenhaus Düsseldorf

Spots Global Cancer Trial Database for motorized spiral endoscopy