| CTRI Number |
CTRI/2025/08/093539 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Magnetic Resonance Enterography- a type of MRI scan for assessing intestinal related diseases |
|
Scientific Title of Study
|
Role of magnetic resonance enterography in assessment of bowel diseases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhi Gaur |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Radiodiagnosis, Superspeciality block, AVBRH, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
8057293173 |
| Fax |
|
| Email |
gaurshubhi46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PH PARIHAR |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of radiodiagnosis, Superspeciality block, Acharya Vinobha Bhave Rural Hospital, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422104957 |
| Fax |
|
| Email |
drphparihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhi Gaur |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Radiodiagnosis, Superspeciality block, Acharya Vinobha Bhave Rural Hospital, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
8057293173 |
| Fax |
|
| Email |
gaurshubhi46@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Acharya Vinobha Bhave Rural Hospital |
| Address |
JNMC Campus, Sawangi, Maharaashtra, 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubhi Gaur |
Datta Meghe Institute Higher Education and Research |
Department of Radiodiagnosis, Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA |
8057293173
gaurshubhi46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical sciences Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing MR enterography for various bowel disorders |
|
| ExclusionCriteria |
| Details |
1.Patient with severe vomiting
2.Patient with general contraindication for MRI (metallic implants/ pacemaker/ cochlear implant)
3.Pregnant patients
4.Patients with claustrophobia/any other psychiatric abnormality
• Uncooperative/unwilling patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the benefits of MR enterography in diagnosing and characterizing bowel diseases. |
every 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To correlate MR enterography findings with endoscopy findings & Histopathological reports.
• To assess the sensitivity & specificity of MR enterography in diagnosing bowel disease. |
every 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
At the end of this study, the goal would be to establish MRE to have a positive impact on clinicians’ diagnostic confidence and treatment plans by guiding prompt and targeted therapy, evaluating disease phenotype, extent, and activity, and defining the presence or absence of complications. |