NCT05548140

Brief Summary

STUDY OBJECTIVES:

  1. 1.Primary objective: Rate of total enteroscopy (TER) by means of NMSE or SBE with: Complete antegrade approach or combined antegrade and retrograde approach
  2. 2.Secondary objective:
  3. 3.Technical success of anterograde and retrograde approach
  4. 4.Procedural time (minutes)
  5. 5.Depth of maximum insertion (cm)
  6. 6.Diagnostic yield
  7. 7.Therapeutic success
  8. 8.Adverse events

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 25, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

May 25, 2022

Last Update Submit

March 24, 2023

Conditions

Small Bowel Disease

Keywords

Small bowel diseaseIBDSingle balloon enteroscopyspiral enteroscopy

Outcome Measures

Primary Outcomes (1)

  • Rate of total enteroscopy (TER)

    Number of cases in which total small bowel examination can be performed

    1 year

Secondary Outcomes (6)

  • Technical success of anterograde and retrograde approach

    1 year

  • Procedural time (minutes)

    1 year

  • Depth of maximum insertion (cm)

    1 year

  • Diagnostic yield

    1 year

  • Therapeutic success

    1 year

  • +1 more secondary outcomes

Study Arms (2)

NOVEL MOTORIZED SPIRAL ENTEROSCOPY

EXPERIMENTAL

This arm involves performance of spiral enteroscopy using a specialized enteroscope under general anaesthesia in patients who fulfill the inclusion criteria.

Device: Novel Motorized Spiral Enteroscopy

SINGLE BALLOON ENTEROSCOPY

ACTIVE COMPARATOR

This arm involves performance of single balloon enteroscopy using a specialized single balloon enteroscope in patients who fulfill inclusion criteria.

Device: Novel Motorized Spiral Enteroscopy

Interventions

Novel Motorized Spiral EnteroscopyDEVICE

This study involves performance of spiral enteroscopy in one arm and single balloon enteroscopy in the other arm in patients who satisfy inclusion criteria

Also known as: Single Balloon Enteroscopy
NOVEL MOTORIZED SPIRAL ENTEROSCOPYSINGLE BALLOON ENTEROSCOPY

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with small bowel disease with an indication for total enteroscopy with indeterminate imaging findings (as defined above)
  • Age \> 18 years
  • Patients willing to give written consent

You may not qualify if:

  • Positive imaging findings (as defined)
  • Age \< 18 years.
  • Contraindications for endoscopy due to comorbidities
  • Unable to provide written informed consent
  • Patients with known severe GI tract inflammation, intestinal obstruction, gastroesophageal varices that preclude a safe enteroscopy procedure
  • Coagulopathy or thrombocytopenia that couldn't be corrected by blood product transfusion
  • Pregnant patients
  • Health status American Society of Anaesthetist Classification (ASA) \>3
  • Inability to tolerate sedation or general anaesthesia for any reason
  • Pediatrics patients (infants and toddlers)
  • Eosinophilic esophagitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hardik Rughwani

Hyderabad, Other, 500032, India

Location

AIG Hospitals

Hyderabad, Telangana, 500032, India

Location

Related Publications (4)

  • 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: 32663489BACKGROUND

  • Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/a-0576-0566. Epub 2018 Mar 14.

    PMID: 29539652BACKGROUND

  • Buscaglia JM, Dunbar KB, Okolo PI 3rd, Judah J, Akerman PA, Cantero D, Draganov PV. The spiral enteroscopy training initiative: results of a prospective study evaluating the Discovery SB overtube device during small bowel enteroscopy (with video). Endoscopy. 2009 Mar;41(3):194-9. doi: 10.1055/s-0028-1119602. Epub 2009 Mar 11.

    PMID: 19280530BACKGROUND

  • Yamamoto H, Ogata H, Matsumoto T, Ohmiya N, Ohtsuka K, Watanabe K, Yano T, Matsui T, Higuchi K, Nakamura T, Fujimoto K. Clinical Practice Guideline for Enteroscopy. Dig Endosc. 2017 Jul;29(5):519-546. doi: 10.1111/den.12883. Epub 2017 Jun 9.

    PMID: 28370422RESULT

Related Links

MeSH Terms

Interventions

Single-Balloon Enteroscopy

Intervention Hierarchy (Ancestors)

Balloon EnteroscopyEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Dr Hardik Rughwani, MBBS, MD, DM

    AIG Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gastroenterologist

Study Record Dates

First Submitted

May 25, 2022

First Posted

September 21, 2022

Study Start

September 20, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(2)