Ongoing Clinical Trials Related to Colonoscopy
Currently, there are 4 ongoing clinical trials focused on colonoscopy procedures. These studies are investigating different aspects of colonoscopy, including bowel preparation methods, management of medications during polyp removal, and sedation techniques to improve patient comfort and safety during the procedure.
Clinical trial locations
- Belgium
- Denmark
- Italy
- Poland
- Spain
- Sweden
Efficacy and Safety of Mannitol Compared to Plenvu for Bowel Preparation in Patients Undergoing Elective Colonoscopy
This international study is comparing two different methods of preparing the bowel before a planned colonoscopy. The trial is testing whether mannitol, a sugar alcohol used as a bowel cleanser, works as well as Plenvu, a commercially available bowel preparation solution.
Inclusion criteria: To participate, you must be at least 18 years old and scheduled for a planned colonoscopy performed according to standard European medical guidelines. You must be able to understand the study information and provide written consent. The study is open to both men and women who are willing and able to complete the entire study and follow all instructions.
Exclusion criteria: You cannot join if you have a known allergy to mannitol or Plenvu, severe kidney problems, bowel obstruction, inflammatory bowel disease such as Crohn’s disease or ulcerative colitis, or have had previous bowel surgery that significantly changed your digestive anatomy. Pregnant or breastfeeding women, people with severe heart failure, those unable to follow instructions independently, or anyone currently participating in another clinical trial are also excluded.
Study focus: The main goal is to determine if mannitol is at least as effective as Plenvu for cleaning the bowel before colonoscopy when used on the same day as the procedure. Participants will be randomly assigned to receive either mannitol or Plenvu. The doctor performing the colonoscopy will not know which preparation was used, allowing for an unbiased assessment. The study will measure how well each preparation cleans the bowel and will collect feedback from patients about their experience, including ease of use, taste, and willingness to use it again. Blood samples and vital signs will be monitored at various points during the study.
Investigational medications: Mannitol works by drawing water into the intestines to produce watery diarrhea, helping to clear the colon. Plenvu contains a combination of ingredients that work together to cleanse the bowel through a similar mechanism.
Study Comparing Bowel Cleansing Agents Plenvu and Picoprep for Patients Undergoing Colonoscopy to Exclude Colorectal Cancer
This Danish study is comparing two bowel cleansing products for patients who are having a colonoscopy to check for colorectal cancer. The trial compares Plenvu, a newer low-volume preparation, with Picoprep, a well-established bowel preparation.
Inclusion criteria: You must be scheduled for an outpatient colonoscopy and be over 18 years of age. Both men and women can participate. The study does not include vulnerable populations.
Exclusion criteria: You cannot participate if you are not being referred for a colonoscopy to check for colorectal cancer, are outside the study age range, belong to a vulnerable population, have medical conditions that might interfere with the study or your safety, cannot follow study procedures, have allergies to ingredients in the bowel cleansing agents, are currently in another clinical trial, have had recent surgery or procedures that might affect the study, are pregnant or breastfeeding, or have a history of certain digestive system diseases.
Study focus: The main purpose is to determine if Plenvu is as effective as Picoprep in cleaning the bowel and whether it is easier for patients to tolerate. Participants will be randomly assigned to receive either Plenvu or Picoprep and will provide feedback about their experience with the preparation. The study will assess the quality of bowel cleansing during the colonoscopy and monitor for any side effects.
Investigational medications: Plenvu is a low-volume solution containing ascorbic acid (Vitamin C), sodium ascorbate, potassium chloride, sodium chloride, and macrogol 3350. Picoprep contains sodium picosulfate, magnesium oxide, and citric acid. Both are taken orally to empty and clean the colon.
Study on the Safety of Continuing Apixaban, Clopidogrel, and Rivaroxaban During Polyp Removal in Patients on Antiplatelet or Anticoagulant Therapy
This Spanish study is investigating whether it is safe to continue taking blood-thinning medications during a procedure to remove small polyps from the colon. The trial focuses on patients taking antiplatelet or anticoagulant medications, which help prevent blood clots but can increase bleeding risk.
Inclusion criteria: You must be between 18 and 80 years old and scheduled for a colonoscopy for any reason. You must be taking long-term antiplatelet therapy (except aspirin) or anticoagulant medication. Both men and women can participate, and you should not be part of a vulnerable population.
Exclusion criteria: The exclusion criteria were not clearly specified in the provided information beyond the general statement that certain patients on antiplatelet or anticoagulant medications may not be eligible.
Study focus: The main goal is to determine whether continuing blood-thinning medications during cold snare polypectomy (a technique for removing small polyps) leads to a similar bleeding risk compared to stopping these medications according to current guidelines. The study will monitor patients for any signs of bleeding during and after the procedure. Several medications are being studied, including apixaban, clopidogrel, rivaroxaban, dabigatran etexilate, edoxaban, and acenocoumarol. The study will last up to eight weeks for each participant.
Investigational medications: The study examines various antiplatelet and anticoagulant medications that help prevent blood clots. These include medications that stop blood cells from sticking together and those that thin the blood to prevent clot formation.
Study on Sedation for Colonoscopy: Comparing Remimazolam with Fentanyl and Midazolam with Fentanyl in Screening Patients
This Danish trial is comparing two different sedation methods used during screening colonoscopy for colon cancer. The study evaluates whether using remimazolam with fentanyl can improve the procedure and recovery time compared to using midazolam with fentanyl.
Inclusion criteria: You must be over 18 years old, scheduled for a planned colonoscopy to check for colon cancer, and able to provide written consent after understanding the study details.
Exclusion criteria: You cannot participate if you are not undergoing a screening colonoscopy, are not within the specified age range, or are part of a vulnerable population with limited ability to give informed consent or at higher risk of harm.
Study focus: The main objective is to determine if remimazolam with fentanyl can make the sedation process quicker and more comfortable compared to midazolam with fentanyl. The study will measure the time from the start of medication until the patient is ready to be safely discharged. Other aspects being observed include recovery room time, comfort and pain levels, how quickly the procedure reaches a certain point in the colon, whether additional doses are needed, satisfaction of both patients and doctors, and patients’ thinking ability at discharge. The medications will be given through an intravenous line directly into a vein.
Investigational medications: Remimazolam is a medication that helps patients relax and feel sleepy during procedures and is being tested to see if it allows for faster recovery. Fentanyl is a strong pain reliever used to ensure patient comfort during the procedure. Midazolam is another sedative commonly used for colonoscopy but is being compared to remimazolam in this study.
Summary
These four ongoing clinical trials address different aspects of improving the colonoscopy experience for patients. Two studies focus on bowel preparation methods, comparing different cleansing solutions to find options that are both effective and easier for patients to tolerate. One trial examines the safety of continuing blood-thinning medications during polyp removal, which could help simplify medication management for patients who need these drugs long-term. Another study investigates sedation techniques to potentially reduce procedure and recovery time.
Geographically, the trials show activity across multiple European countries, with studies taking place in Denmark, Spain, Italy, Poland, Belgium, and Sweden. Denmark hosts two trials, while the largest multi-country trial spans five nations. The research demonstrates a focus on patient comfort and safety, with particular attention to bowel preparation quality and medication management during procedures. Several studies specifically mention Plenvu as a comparator, indicating interest in establishing benchmarks for newer bowel preparation methods.
