The BOOM-IBD2 Study may be right for you.
The BOOM-IBD2 Study is evaluating the effectiveness of sacral neuromodulation (SNM) for people with Ulcerative Colitis who experience ongoing bowel urgency symptoms (the sudden need to rush to the bathroom). To be considered for the study, you must have a diagnosis of Ulcerative Colitis and be experiencing bowel urgency symptoms.
The goal of the study is to determine whether this investigational therapy may reduce bowel urgency and may improve quality of life in people with Ulcerative Colitis.
Other study requirements will apply. If you choose to participate, the study team will provide more information. Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
What is the BOOM-IBD2 Treatment?
Sacral neuromodulation (SNM) is a type of nerve stimulation treatment that uses gentle electrical signals to stimulate nerves near the sacrum (lower back) that are involved in bowel control. To stimulate the sacral nerves, an investigational device will be implanted and activated during the study implantation procedure.
What is the BOOM-IBD2 Procedure?
The procedure involves implantation of the study device. The type of anesthesia will be determined by the study site according to its standard of care. A small device is implanted under the skin and connected to a lead placed near the sacral nerves. Participants use a patient programmer to manage their therapy during the study. All necessary details will be provided by the study site.
What is Ulcerative Colitis?
Ulcerative Colitis is a chronic inflammatory bowel disease that affects the lining of the colon (large intestine) and rectum. In the United States, Ulcerative Colitis affects an estimated 400 per 100,000 people. In Ulcerative Colitis, the inflammation typically begins in the rectum and may extend continuously through part or all of the colon. Symptoms include bowel urgency, diarrhea, rectal bleeding, and abdominal pain, and typically follow a pattern of flare-ups and remission. It is a long-term condition that can significantly impact a person’s quality of life due to recurring symptoms and the need for ongoing management. Bowel urgency is one of the most disruptive symptoms and a key focus in this study.
Living with Ulcerative Colitis can be challenging. Sacral neuromodulation is being evaluated in this study to determine whether it can reduce bowel urgency in adults with Ulcerative Colitis. If you are interested in learning more about BOOM-IBD2 Study or want to see if you qualify to participate in the Study, take this brief pre-screening questionnaire.
FAQ of Clinical Trials
Below are some common questions and answers about taking part in a clinical trial.
Taking part in a clinical trial usually involves attending regular clinic visits, receiving an investigational medicine, device or treatment, and undergoing assessments to monitor your health and the effects of the study treatment.
You can continue to see your regular doctor throughout the study. If you decide to participate, you should let your doctor know that you are taking part in a clinical trial. Participation in a clinical trial is voluntary, and you may withdraw at any time.
No. There is no cost to participants for study-related care, tests or procedures. Reimbursement may also be available for reasonable study-related expenses, such as travel. The study team will provide more information about any available reimbursements or compensation.
Yes. Participation is entirely voluntary, and you may withdraw from a study at any time without providing a reason. While you are not required to explain your decision, any feedback you choose to provide may help researchers improve future studies. Deciding not to participate, or choosing to withdraw from a study, will not affect your regular medical care.
Clinical trials help researchers develop new ways to prevent, diagnose and treat medical conditions. By taking part, participants contribute to medical research that may help develop new treatment options. Clinical trials may investigate new medical devices, procedures and medicines or new ways of using existing treatments.
A single-arm clinical trial is a study in which there is no separate placebo or comparison group. In this study, participants who are successfully implanted receive active SNM treatment, and researchers assess how symptoms change over time compared with before treatment.
Investigational means that the use of the device for Ulcerative Colitis is currently being evaluated in a clinical research study. While sacral neuromodulation (SNM) technology is approved and used globally for certain other medical conditions, this study is investigating its use for bowel urgency associated with Ulcerative Colitis. The use of SNM for bowel urgency associated with Ulcerative Colitis has not been approved for use outside this study by regulatory authorities, including the U.S. Food and Drug Administration (FDA).
Before deciding whether to participate, you will be given an Informed Consent Form (ICF). This document explains the purpose of the study, what participation involves, the potential risks and benefits, and your rights as a participant. You will have the opportunity to ask questions and take time to consider whether participation is right for you before signing the consent form.
Participant safety is the highest priority in clinical research. Clinical trials are conducted according to strict ethical and scientific standards, including Good Clinical Practice (GCP) guidelines and the principles of the Declaration of Helsinki.
These standards help ensure that:
- Participation is voluntary.
- Participants are provided with the information needed to make informed decisions.
- Participants' rights, safety and wellbeing are protected.
- The wellbeing of participants takes priority over the interests of science and society.
The study team will closely monitor participants throughout the study, and any potential risks will be explained before participation.
