NCT03000361

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

December 15, 2016

Last Update Submit

July 28, 2017

Conditions

ColonoscopySafety IssuesAdenoma

Keywords

Colonoscopymotorized spiral endoscopyadenoma detection rate

Outcome Measures

Primary Outcomes (1)

  • Cecal intubation rate

    3 days

Secondary Outcomes (10)

  • Ileum intubation rate

    3 days

  • Procedure time

    3 days

  • rate of need for external compression

    3 days

  • adenoma detection rate

    3 days

  • success rate for removal of polyps

    3 days

  • +5 more secondary outcomes

Study Arms (1)

Motorized Spiral Colonoscopy

EXPERIMENTAL

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

Procedure: Motorized Spiral Colonoscopy

Interventions

Motorized Spiral ColonoscopyPROCEDURE

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

Also known as: standard endoscopic interventions (not experimental)
Motorized Spiral Colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Screening for colorectal neoplasia
  • Surveillance after previous polypectomy/endoscopic mucosal resection (EMR)
  • Positive results on colorectal cancer (CRC) screening tests
  • Evaluation of clinical symptoms of non overt gastrointestinal bleeding
  • Indeterminate iron-deficiency anaemia
  • Chronic diarrhoea
  • Indeterminate large-bowel symptoms requiring evaluation for colorectal disease

You may not qualify if:

  • Age under 18 years
  • Health status American Society of Anesthesiologists classification (ASA) level ≥ 3
  • Pregnancy
  • Known coagulopathy (INR≥2.0, Platelets \< 70/nl)
  • Anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
  • History of chronic inflammatory bowel disease
  • Previously identified colorectal polyps/lesions with indication for endoscopic resection
  • Any medical contraindication to standard colonoscopy
  • Any prior abdominal surgery of the mid or lower gastrointestinal tract (except uncomplicated appendectomy)
  • Known or suspected bowel obstruction or stenosis
  • Known hemorrhoids 3rd degree
  • Suspected perforation of the GI tract
  • Inability to tolerate sedation for any reason
  • Absence of a signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Related Publications (1)

  • Beyna T, Schneider M, Pullmann D, Gerges C, Kandler J, Neuhaus H. Motorized spiral colonoscopy: a first single-center feasibility trial. Endoscopy. 2018 May;50(5):518-523. doi: 10.1055/s-0043-123577. Epub 2017 Dec 18.

    PMID: 29253918DERIVED

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Horst Neuhaus, MD, PhD

    Evangelisches Krankenhaus Duesseldorf, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 22, 2016

Study Start

December 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)