Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 4:12 AM
Study NCT ID:
NCT04959994
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2021-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Small Bowel Evaluation Using Novel Motorized Spiral Enteroscopy
Sponsor:
Asian Institute of Gastroenterology, India
Organization:
Study Overview
Official Title:
Small Bowel Evaluation Using Novel Motorized Spiral Enteroscopy - Prospective Non-controlled Clinical Study From a Single Tertiary Care Centre.
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
1. Introduction Few studies have been published till now 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 centre including the follow up at 1 month for any adverse events. This will help us to develop our understanding the role of Novel Motorized Spiral Enteroscopy in the small bowel evaluation.
2. Rationale Prospective study evaluating the efficacy of the Novel Motorized Spiral Enteroscopy is lacking. This study will help in understanding the efficacy and safety of the procedure in the evaluation of the small bowel diseases.
3. Study Population All the patients who will undergo small bowel evaluation using Novel Motorized Spiral Enteroscopy at AIG Hospitals, Gachibowli, Hyderabad, Telangana, India
4. Methodology Patients with suspected small bowel disease with an indication for total enteroscopy will undergo Novel Motorized Spiral Enteroscopy at AIG hospitals. Patient record including the Demographic details, Indications, Pre-Anaesthesia evaluation, History of any previous surgery or prior enteroscopy. Procedure technical success, Total enteroscopic small bowel evaluation rate or extent of examination. Therapeutic procedure underwent, Total Procedure time, Diagnosis, Recovery from anaesthesia time record will be maintained. All the patients will be followed up telephonically for any possible adverse event upto 30 days.
Patient details will be recorded in a proforma after taking proper informed consent.
4a. Inclusion Criteria
1. Patients with small bowel disease with an indication for Motorized spiral enteroscopy
2. Overt or obscure Gastrointestinal bleeding
3. Iron deficiency anaemia
4. Chronic diarrhoea
5. Abdominal pain for evaluation with suspected small bowel involvement.
6. IBD requiring small bowel evaluation
7. Polyposis syndrome requiring small bowel evaluation
8. Small bowel subacute obstruction
9. Refractory celiac disease
4b. Exclusion criteria
1. Weight less than 30 kg
2. Large gastric or oesophageal varices
3. Any medical contraindication to standard enteroscopy
4. Any prior history of gastric , small bowel , large bowel surgery
5. Acute obstruction of small bowel
6. Suspected GI perforation
7. Any contraindication for general anaesthesia
8. Lack of informed consent.
4c. Subject recruitment All the patients who will undergo the procedure according to the inclusion and exclusion criteria will be taken. Prospectively their records will be maintained by proforma at AIG hospitals, Gachibowli.
4d. Randomization and blinding - NIL Single group assignment with no randomization
4e. Method of assessment This will be a non- controlled single group assignment study,All antegrade power spiral enteroscopy procedures will be performed under elective general anesthesia with nasotracheal intubation.Retrograde power spiral enteroscopy procedures will be performed under deep sedation using propofol.A prophylactic wire guided dilatation using Savary - Gilliard dilator up to 20 mm will be done in all the patients. After the maximal depth of insertion via the antegrade route hemoclip or Indiaink will be applied to mark the maximal depth of insertion and retrograde enteroscopy will be done to try to trace the hemoclip on the same or the next day to obtain total enteroscopy.
4f. Stopping or discontinuation criteria- None
5\. Sample size calculation All the patients who will undergo Novel Motorized Spiral Enteroscopy will be recorded in a proforma and their follow up at 30 days will be assessed telephonically for a duration of 1 year
6\. Statistical analysis The database will be created with Microsoft Excel (Microsoft, Seattle, Wash, USA). Data entry will be done by primary investigator using google forms and it will be stored with the primary investigator. Statistical analyses will be done using SPSS version 25 (IBM Corp., Armonk, NY, USA). Continuous measures will be expressed with sample size, mean (standard deviation), median (range), as and when required. Categorical measures will be presented as number of patients and percentage. The 95% confidence interval will be calculated using exact Clopper-Pearson for diagnostic yield and TER.
7\. Ethical justification of the study This is a prospective nonrandomized non-controlled trial with patients not assigned to any specific intervention.
2. Rationale Prospective study evaluating the efficacy of the Novel Motorized Spiral Enteroscopy is lacking. This study will help in understanding the efficacy and safety of the procedure in the evaluation of the small bowel diseases.
3. Study Population All the patients who will undergo small bowel evaluation using Novel Motorized Spiral Enteroscopy at AIG Hospitals, Gachibowli, Hyderabad, Telangana, India
4. Methodology Patients with suspected small bowel disease with an indication for total enteroscopy will undergo Novel Motorized Spiral Enteroscopy at AIG hospitals. Patient record including the Demographic details, Indications, Pre-Anaesthesia evaluation, History of any previous surgery or prior enteroscopy. Procedure technical success, Total enteroscopic small bowel evaluation rate or extent of examination. Therapeutic procedure underwent, Total Procedure time, Diagnosis, Recovery from anaesthesia time record will be maintained. All the patients will be followed up telephonically for any possible adverse event upto 30 days.
Patient details will be recorded in a proforma after taking proper informed consent.
4a. Inclusion Criteria
1. Patients with small bowel disease with an indication for Motorized spiral enteroscopy
2. Overt or obscure Gastrointestinal bleeding
3. Iron deficiency anaemia
4. Chronic diarrhoea
5. Abdominal pain for evaluation with suspected small bowel involvement.
6. IBD requiring small bowel evaluation
7. Polyposis syndrome requiring small bowel evaluation
8. Small bowel subacute obstruction
9. Refractory celiac disease
4b. Exclusion criteria
1. Weight less than 30 kg
2. Large gastric or oesophageal varices
3. Any medical contraindication to standard enteroscopy
4. Any prior history of gastric , small bowel , large bowel surgery
5. Acute obstruction of small bowel
6. Suspected GI perforation
7. Any contraindication for general anaesthesia
8. Lack of informed consent.
4c. Subject recruitment All the patients who will undergo the procedure according to the inclusion and exclusion criteria will be taken. Prospectively their records will be maintained by proforma at AIG hospitals, Gachibowli.
4d. Randomization and blinding - NIL Single group assignment with no randomization
4e. Method of assessment This will be a non- controlled single group assignment study,All antegrade power spiral enteroscopy procedures will be performed under elective general anesthesia with nasotracheal intubation.Retrograde power spiral enteroscopy procedures will be performed under deep sedation using propofol.A prophylactic wire guided dilatation using Savary - Gilliard dilator up to 20 mm will be done in all the patients. After the maximal depth of insertion via the antegrade route hemoclip or Indiaink will be applied to mark the maximal depth of insertion and retrograde enteroscopy will be done to try to trace the hemoclip on the same or the next day to obtain total enteroscopy.
4f. Stopping or discontinuation criteria- None
5\. Sample size calculation All the patients who will undergo Novel Motorized Spiral Enteroscopy will be recorded in a proforma and their follow up at 30 days will be assessed telephonically for a duration of 1 year
6\. Statistical analysis The database will be created with Microsoft Excel (Microsoft, Seattle, Wash, USA). Data entry will be done by primary investigator using google forms and it will be stored with the primary investigator. Statistical analyses will be done using SPSS version 25 (IBM Corp., Armonk, NY, USA). Continuous measures will be expressed with sample size, mean (standard deviation), median (range), as and when required. Categorical measures will be presented as number of patients and percentage. The 95% confidence interval will be calculated using exact Clopper-Pearson for diagnostic yield and TER.
7\. Ethical justification of the study This is a prospective nonrandomized non-controlled trial with patients not assigned to any specific intervention.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: