NCT04959994

Brief Summary

Small bowel evaluation using Novel Motorized Spiral Enteroscopy - Prospective non-controlled clinical study from a single tertiary care centre. Data regarding the safety and efficacy of Novel Motorized Spiral Enteroscopy in the evaluation of the small bowel, most of them are retrospective. This study is being planned to collect the data prospectively for all the patients undergoing this procedure at our center including the follow up at 1 month for any adverse events.This will enlighten us in understanding the role of Novel Motorized Spiral in the evaluation of the small bowel Enteroscopy in the small bowel evaluation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 15, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2022

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

July 2, 2021

Last Update Submit

April 29, 2022

Conditions

Small Bowel Disease

Keywords

Small bowel diseaseDeep enteroscopy

Outcome Measures

Primary Outcomes (1)

  • Total enteroscopy rate with motorized spiral enteroscopy both via antegrade and the retrograde route.

    Rate of examining the total small bowel evaluation using novel motorized spiral enteroscopy

    2 days

Secondary Outcomes (6)

  • Technical success of antegrade and the retrograde approach

    2 days

  • Total procedural time

    2 days

  • Depth of the maximal insertion

    2 days

  • Diagnostic yield

    2 days

  • Therapeutic yield

    2 days

  • +1 more secondary outcomes

Interventions

Novel Motorized Spiral EnteroscopyDEVICE

All the patients with suspected small bowel disease and an indication to undergo total enteroscopy and satisfying inclusion criteria will undergo novel motorized spiral enteroscopy

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients with suspected small bowel disease satisfying the inclusion criteria and have indications for total enteroscopy will undergo small bowel evaluation using Novel Motorized Spiral Enteroscopy.

You may qualify if:

  • Patients with small bowel disease with an indication for Motorized spiral enteroscopy and age more than 10 years
  • Overt or obscure Gastrointestinal bleeding
  • Iron deficiency anaemia
  • Chronic diarrhoea
  • Abdominal pain for evaluation with suspected small bowel involvement.
  • IBD requiring small bowel evaluation
  • Polyposis syndrome requiring small bowel evaluation
  • Small bowel subacute obstruction
  • Refractory celiac disease

You may not qualify if:

  • Weight less than 30 kg
  • Large gastric or oesophageal varices
  • Any medical contraindication to standard enteroscopy
  • Any prior history of gastric , small bowel , large bowel surgery
  • Acute obstruction of small bowel
  • Suspected GI perforation
  • Any contraindication for general anaesthesia
  • Lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aniruddha Pratap Singh

Hyderabad, Telangana, 500089, India

RECRUITING

Related Publications (3)

  • Beyna T, Arvanitakis M, Schneider M, Gerges C, Hoellerich J, Deviere J, Neuhaus H. Total motorized spiral enteroscopy: first prospective clinical feasibility trial. Gastrointest Endosc. 2021 Jun;93(6):1362-1370. doi: 10.1016/j.gie.2020.10.028. Epub 2020 Nov 2.

    PMID: 33144239RESULT

  • 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.

    PMID: 32332141RESULT

  • Ramchandani M, Rughwani H, Inavolu P, Singh AP, Tevethia HV, Jagtap N, Sekaran A, Kanakagiri H, Darishetty S, Reddy DN. Diagnostic yield and therapeutic impact of novel motorized spiral enteroscopy in small-bowel disorders: a single-center, real-world experience from a tertiary care hospital (with video). Gastrointest Endosc. 2021 Mar;93(3):616-626. doi: 10.1016/j.gie.2020.07.001. Epub 2020 Jul 12.

    PMID: 32663489RESULT

Study Officials

  • Aniruddha P Singh, MBBS,MD,DM

    AIG hospitals,India

    PRINCIPAL INVESTIGATOR

  • Mohan Ramchandani, MBBS,MD,DM

    AIG Hospitals,India

    STUDY DIRECTOR

  • Duvur Nageshwar Reddy

    AIG Hospitals,India

    STUDY CHAIR

Central Study Contacts

Aniruddha P Singh, MBBS,MD,DM

CONTACT

09004093248draniruddhapratapsingh@gmail.com

Mohan Ramchandani, MBBS,MD,DM

CONTACT

+919701335444ramchandanimohan@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 13, 2021

Study Start

June 15, 2021

Primary Completion

June 16, 2022

Study Completion

June 16, 2022

Last Updated

May 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)