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Colonoscopy clinical trials

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NCT ID: NCT05718193 Completed - Colonoscopy Clinical Trials

Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.

NCT ID: NCT05674500 Completed - Colonoscopy Clinical Trials

Coaching Language to Improve Endoscopy Training Quality

CLIEnT
Start date: March 23, 2022
Phase: N/A
Study type: Interventional

The goal of this randomized control study is to determine if the use of standardized coaching language by faculty trainers for teaching colonoscopy is associated with improved colonoscopy performance. The main questions it aims to answer are: - If the use of standardized coaching language is effective in improving colonoscopy training? - If the use of standardized coaching language influences the clarity of instructions by the faculty trainers during colonoscopy teaching Participants will take part in simulated colonoscopy teaching encounter using a virtual reality simulator for 1 hour in 2 different sessions 2 weeks apart. Researchers will compare 2 groups of faculty trainers to to see if the standardized coaching language effects the colonoscopy training quality.

NCT ID: NCT05626738 Completed - Colonoscopy Clinical Trials

Endorail in Long Lasting Colonoscopy

Start date: January 25, 2023
Phase: N/A
Study type: Interventional

Patients with long lasting colonoscopy are characterized by higher risk of incompletion. Endorail is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. Endorail works as a magnetic anchor that is able to guide the colonoscope and to straighten colon curves and loops. The aim of this study is to test the safety and efficacy of Endorail in ensuring that incompletion rate in long-lasting colonoscopies is lower than the 10% threshold. Outpatients of either sex aged between 22-75 years undergoing elective diagnostic or surveillance colonoscopy with caecal intubation time greater than 10 minutes will take part in the study. The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete long-lasting colonoscopies. The primary safety endpoints are the absence of device-related serious adverse events and the evaluation of the equality or reduction of the adverse events rates compared to diagnostic colonoscopies without Endorail.

NCT ID: NCT05570669 Completed - Colonoscopy Clinical Trials

Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.

ERACLES
Start date: May 25, 2021
Phase: Phase 4
Study type: Interventional

Multicenter, prospective, randomized, checked, open label, with blind evaluation, for compare the intestinal cleansing effectiveness of the regimen full-dose delayed (A) of Clensia vs split regimen (B) of Clensia, in patients undergoing endoscopy.

NCT ID: NCT05519098 Completed - Colonoscopy Clinical Trials

COLO-SW-1 Pivotal Clinical Investigation

Start date: August 23, 2022
Phase:
Study type: Observational

The Clinical Investigation is a summative usability study and a 'first-in-patient'-study of the independent medical device software (MDSW) utilizing artificial intelligence. The MDSW has completed the development phase and is ready to enter production. The primary objective of this study is to assess the user safety and secondary the user-friendliness of the MDSW to confirm compliance to certain General safety and performance requirements (GSPR) set by the MDR. The software to assess will be installed in a medical grade PC to allow the use of the MDSW according to its intended purpose of detecting colorectal polyps. However, the PC is not a part of the medical device under investigation and its performance and safety will not be assessed by this investigation. The intended purpose and clinical benefit of the MDSW is to assist the endoscopist in detecting more polyps, with the possibility of subsequently preventing colorectal cancer later on. The data obtained from the investigation will be used for regulatory purposes aiming to obtain a CE certification as class IIa according to MDR for the MDSW under investigation. The multi-center investigation will assess 8-20 endoscopists experience with the MDSW and whether technical difficulties occur during its use in one site. The user experience of the endoscopists will be collected in a questionnaire form. The investigator will additionally record any possible adverse effects (AE) or adverse technical effects (ATE) of the use of the MDSW. The MDSW will be used during ordinary colonoscopy in adult, out-patients ≥18 years but variables related to the patient outcome will not be assessed. Patients with inadequate bowel preparation, active inflammation, cecum not reached or not consenting will be excluded from the study. Each endoscopist will assess the device during 3-5 patient examinations. The primary objective of the investigation is to confirm that COLO-SW-1 is safe for use during colonoscopy as intended for aiding in detection of polyps. The secondary objective is to assess the user-friendliness of the MDSW interface. The clinical investigation is estimated to start in August 2022. The participation of the endoscopists will take place continuously through the clinical investigation until required number (up to 20) of participants has been reached. When 8 participants have been included in total, an interim analysis is made, and the Principal Investigator decides if the confirmatory objectives have been met. A conclusion can be drawn from the partial objectives met at this point. The study can continue for up to 20 participants to complete all endpoints, if required. The investigation will be closed by end of October 2022. The investigation will be deemed completed once the last evaluation form has been completed by the endoscopists.

NCT ID: NCT05447403 Completed - Constipation Clinical Trials

Effect of Chewing Gum and WeChat Enhanced Instructions on the Bowel Preparation Quality in Patients With Constipation

Start date: February 24, 2022
Phase: N/A
Study type: Interventional

Patients with constipation are more likely to have poor bowel preparation quality due to slow gut motility and poor emptying ability. Gum chewing, as a proxy of sham feeding, is a very simple way used to accelerate gut motility. And a previous study found that enhanced instructions by WeChat could improve bowel preparation quality. Thus, investigators conducted a single-center randomized controlled trial to explore the effect of chewing gum combined with manual enhanced instructions by WeChat on the bowel preparation quality for colonoscopy in patients with constipation.

NCT ID: NCT05397158 Completed - Colonoscopy Clinical Trials

Optimization of Intestinal Preparation in Older Patients

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Older adults are susceptible to intestinal tumors. Colonoscopy can screen colorectal cancer, adenoma and other diseases. There is a large demand for colonoscopy in the older adults, and the risk during peri-colonoscopy period is high. According to the common intestinal preparation methods and the characteristics of the older adults, the investigators propose a modified method, that is single administration of low dose polyethylene glycol (PEG). Specifically, take 30ml lactulose in the morning 1 day before the examination, and eat without residue in lunch and dinner, Take 2L PEG in the morning of the examination day and fast at breakfast and lunch of the day. Taking 4L PEG in 2 days as the control group. The fasting and diarrhea period is shorter in the modified group than that in the control group, and the dose of PEG is less. Lactulose, a laxative, is taken one day before the examination, and the intestinal preparation time is longer than that of single administration. The situation of comfort, sleep and fecal incontinence during the intestinal preparation of the two groups will be compared. The results of electrolyte, blood glucose and B-type brain natriuretic peptide between the two groups will be also compared. The effect of intestinal preparation will be evaluated by the standardization of Boston intestinal preparation scale, and endoscopist blind method will be used in colonoscopy.

NCT ID: NCT05379491 Completed - Colonoscopy Clinical Trials

Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the colon cleansing quality of linaclotide versus control in adult patients at high risk of inadequate bowel preparation: one group will receive polyethylene glycol solution (PEG) split dose (1 L + 2 L) plus linaclotide and the other group PEG (1 L + 2 L) plus placebo before colonoscopy.

NCT ID: NCT05378165 Completed - Colonoscopy Clinical Trials

Three Distraction Methods for Pain Reduction During Colonoscopy

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

Colonoscopy is a common procedure to evaluate the gastrointestinal tract. The colonoscopy procedure can sometimes be uncomfortable and painful for the patient. The aim of this study was to compare the effects on pain and anxiety of distraction methods used during colonoscopy. Single centre, randomized, parallel-group trial. Endoscopy unit of a training and research hospital in northern Turkey A total of 120 patients were recruited and randomized into four groups as music, stress ball, video, and control group. The data were collected using Visual Analog Scale for pain and satisfaction, State-Trait Anxiety Inventory for anxiety, and hemodynamic parameters. Data collection continues

NCT ID: NCT05328219 Completed - Colonoscopy Clinical Trials

Effectiveness of Gum Chewing on Polyethylene Glycol Related Intake Adherence, GI Side Effects and Bowel Preparation

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Problem statement An Experimental Study to assess the effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation among Patients Undergoing Colonoscopy at ILBS, New Delhi. Objectives of the study The objectives of the study are: Primary objective 1. To compare the effect of gum chewing in experimental vs. control groups in terms of PEG Related Intake Adherence, GI side effects and Bowel Preparation among Patients Undergoing Colonoscopy. Secondary objective 1. To find the relationship of total amount of fluid taken with GI side effects and Bowel Preparation variables in patients undergoing colonoscopy under experimental group. 2. To determine the association of PEG Related Intake Adherence, GI side effects and Bowel Preparation among Patients with socio-demographic and clinical variables in patients undergoing colonoscopy under experimental group.