GI BleedingNCT05852457
Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip
An observational study of GI Bleeding and Perforation Colon, run by AdventHealth at 2 sites in United States.
Trial summary
This study is designed as a multicenter prospective data recording study to document the performance of the DAT clip as part of standard medical care of patients. No experimental interventions will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI Bleeding, Perforation Colon, Perforation Bowel
- What is being tested?
- DAT Clip
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Aug 2022to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled to undergo endoscopic procedures at participating centers as medically indicated will be considered for the study.
Who may be able to join
- Age 18 years or older.
- Patients scheduled to undergo endoscopic procedures as part of their routine care in which endoscopic clip closure is clinically indicated:
- Treatment of bleeding Treatment of perforation and/or fistulas Tissue approximation for mucosal gaps associated with endoscopic resection (e.g., endoscopic mucosal resection, endoscopic submucosal dissection) or third space endoscopy (e.g., peroral endoscopic myotomy in the gastrointestinal tract)
Who cannot join
- Any contraindications to performing endoscopy.
- Participants in another research protocol that could interfere or influence the outcomes measures of the present study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Parkview Health
Fort Wayne, Indiana, 46845
Neil Sharma, MD, Neil.Sharma@parkview.com
Christina Zelt, MSN, RN,CRC, 260-266-4153, Christina.Zelt@parkview.com
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Dennis Yang, MD, 407-303-2570, Dennis.Yang.MD@adventhealth.com
Diana Paredes, RN, BSN, 407-303-9736, Diana.Paredes@adventhealth.com
About this study
Official title: Prospective Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip
This study is designed as a multicenter prospective data recording study to document the performance of the DAT clip as part of standard medical care of patients. No experimental interventions will be performed.
Read the detailed description
Endoscopic clipping devices are instruments designed to achieve tissue approximation during gastrointestinal endoscopy. Although endoscopic clips were initially developed for the primary purposes of accomplishing hemostasis of focal gastrointestinal bleeding, the indications for endoscopic clipping have expanded to include closure of perforations and fistulas, securing positioning of catheters and stents as well as to provide a radio-opaque markers to direct endoscopic, radiological, and surgical therapy.
Traditionally, through-the-scope (TTS) clipping devices consist of 2 main components: metallic double pronged clips and delivery/deployment catheter-handle assembly. TTS clips are the most used devices for both hemostasis and defect closure given the familiarity and ease of use. However, larger defects or those in a difficult position within the GI tract can be difficult to close using conventional TTS clips alone, given the inherent restrictions in clip opening width and inability to approximate large gaps firmly and securely. Incomplete closure can have serious consequences, including delayed bleeding and need for additional interventions including surgery for treatment of acute perforations.
The Dual Action Tissue (DAT) clip is a novel, Federal Drug and Administration (FDA) approved commercially available 3-arm TTS clip designed for endoscopic closure of large defects. Compared to conventional TTS clips, the DAT clip has an additional center post or fixed column in the middle position. The two arms of the DAT clip operate independent of each other, with an overall maximum opening width angle of 60 degrees. Opening and closing of each arm is controlled by two color-coded handles, which facilitates distinguishment of the clip arms during operation. The arm on one side of the DAT clip is opened to clamp the edge of a defect. The clamped mucosa can then be pulled close to the other side of the defect. The second arm of the DAT is then opened to clamp the opposite edge. Once both edges of the defect are secured by the arms of the DAT clip, the clip can then be deployed by firmly pressing and releasing both handles simultaneously.
Experimental studies using the DAT clip have confirmed its safety and efficacy and shown it to be easy to operate, safe and effective for defect closure. Our initial experience in 6 cases (unpublished data) supports its safety and its utility as an additional endoscopic tool in our armamentarium for challenging tissue approximation. However, more data is needed to evaluate the performance and the role of the DAT clip. The purpose of this study is to prospectively evaluate our experience with the DAT clip as part of routine medical care.
- Conditions
- GI Bleeding, Perforation Colon, Perforation Bowel, Perforation Duodenal, Perforated Bowel, Fistula
- Being tested
- DAT Clip
- Medical subject headings
- Gastrointestinal Hemorrhage, Intestinal Perforation, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAT ClipDevice
All patients scheduled to undergo endoscopic procedures as medically indicated will be considered for the study. Data will be prospectively recorded according to the data collection form. The use of the DAT clip will be performed as medically indicated and consistent with the indications for endoscopic clipping (e.g., management of bleeding, treatment of fistulas, perforations, tissue approximation). The investigators on this project will also oversee the medical care of all patients that will participate in the study. Therefore, follow-up will be carried out as medically indicated and no clinical visits will be needed specifically for the purpose of this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete closure rate.
Cases in which complete tissue approximation is achieved with the use of the DAT clip- no substantial gaps are visible in the closure line.
Measured: 12 months
Secondary outcomes (3)
Rate of Achievement of intended targeted therapy.
Defined as cases in which utilization of the DAT clip accomplished the intended treatment effect (e.g., hemostasis, perforation closure)
Measured: 12 months
Procedural time.
Measure of procedural time associated with the operation of the DAT clip for its intended purpose.
Measured: 12 months
Adverse Events
Measured based on the rate of adverse events with the procedure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start31 Aug 2022
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GI BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Yang, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852457
- Sponsor's protocol ID
- 1931144
- Status last verified
- Aug 2026
- First submitted
- 2 May 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Technology Assessment Committee; Chuttani R, Barkun A, Carpenter S, Chotiprasidhi P, Ginsberg GG, Hussain N, Liu J, Silverman W, Taitelbaum G, Petersen B. Endoscopic clip application devices. Gastrointest Endosc. 2006 May;63(6):746-50. doi: 10.1016/j.gie.2006.02.042. No abstract available.
PubMed 16650531Wang TJ, Aihara H, Thompson AC, Schulman AR, Thompson CC, Ryou M. Choosing the right through-the-scope clip: a rigorous comparison of rotatability, whip, open/close precision, and closure strength (with videos). Gastrointest Endosc. 2019 Jan;89(1):77-86.e1. doi: 10.1016/j.gie.2018.07.025. Epub 2018 Jul 27.
PubMed 30056253Zhang Q, Jin HY, Shen ZH, Ma XJ, Li CQ, Tang Z, Bai Y, Wang Z. Novel through-the-scope twin clip for the closure of GI wounds: the first experimental survival study in pigs (with videos). Gastrointest Endosc. 2021 Oct;94(4):850-858.e2. doi: 10.1016/j.gie.2021.04.027. Epub 2021 May 7.
PubMed 33965383Mohammed A, Gonzaga ER, Hasan MK, Saeed A, Friedland S, Bilal M, Sharma N, Jawaid S, Othman M, Khalaf MA, Hwang JH, Viana A, Singh S, Hayat M, Cosgrove ND, Jain D, Arain MA, Kadkhodayan KS, Yang D. Low delayed bleeding and high complete closure rate of mucosal defects with the novel through-the-scope dual-action tissue clip after endoscopic resection of large nonpedunculated colorectal lesions (with video). Gastrointest Endosc. 2024 Jan;99(1):83-90.e1. doi: 10.1016/j.gie.2023.07.025. Epub 2023 Jul 21.
PubMed 37481003
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip
- ClinicalTrials.gov ID
- NCT05852457
- Acronym / sponsor ID
- 1931144
- Conditions
- GI Bleeding, Perforation Colon, Perforation Bowel, Perforation Duodenal, Perforated Bowel, Fistula
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a multicenter prospective data recording study to document the performance of the DAT clip as part of standard medical care of patients. No experimental interventions will be performed.
Detailed description
Endoscopic clipping devices are instruments designed to achieve tissue approximation during gastrointestinal endoscopy. Although endoscopic clips were initially developed for the primary purposes of accomplishing hemostasis of focal gastrointestinal bleeding, the indications for endoscopic clipping have expanded to include closure of perforations and fistulas, securing positioning of catheters and stents as well as to provide a radio-opaque markers to direct endoscopic, radiological, and surgical therapy.
Traditionally, through-the-scope (TTS) clipping devices consist of 2 main components: metallic double pronged clips and delivery/deployment catheter-handle assembly. TTS clips are the most used devices for both hemostasis and defect closure given the familiarity and ease of use. However, larger defects or those in a difficult position within the GI tract can be difficult to close using conventional TTS clips alone, given the inherent restrictions in clip opening width and inability to approximate large gaps firmly and securely. Incomplete closure can have serious consequences, including delayed bleeding and need for additional interventions including surgery for treatment of acute perforations.
The Dual Action Tissue (DAT) clip is a novel, Federal Drug and Administration (FDA) approved commercially available 3-arm TTS clip designed for endoscopic closure of large defects. Compared to conventional TTS clips, the DAT clip has an additional center post or fixed column in the middle position. The two arms of the DAT clip operate independent of each other, with an overall maximum opening width angle of 60 degrees. Opening and closing of each arm is controlled by two color-coded handles, which facilitates distinguishment of the clip arms during operation. The arm on one side of the DAT clip is opened to clamp the edge of a defect. The clamped mucosa can then be pulled close to the other side of the defect. The second arm of the DAT is then opened to clamp the opposite edge. Once both edges of the defect are secured by the arms of the DAT clip, the clip can then be deployed by firmly pressing and releasing both handles simultaneously.
Experimental studies using the DAT clip have confirmed its safety and efficacy and shown it to be easy to operate, safe and effective for defect closure. Our initial experience in 6 cases (unpublished data) supports its safety and its utility as an additional endoscopic tool in our armamentarium for challenging tissue approximation. However, more data is needed to evaluate the performance and the role of the DAT clip. The purpose of this study is to prospectively evaluate our experience with the DAT clip as part of routine medical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled to undergo endoscopic procedures at participating centers as medically indicated will be considered for the study.
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Patients scheduled to undergo endoscopic procedures as part of their routine care in which endoscopic clip closure is clinically indicated:
- Treatment of bleeding Treatment of perforation and/or fistulas Tissue approximation for mucosal gaps associated with endoscopic resection (e.g., endoscopic mucosal resection, endoscopic submucosal dissection) or third space endoscopy (e.g., peroral endoscopic myotomy in the gastrointestinal tract)
Key exclusion criteria (2 listed)
- Any contraindications to performing endoscopy.
- Participants in another research protocol that could interfere or influence the outcomes measures of the present study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAT ClipAll patients scheduled to undergo endoscopic procedures as medically indicated will be considered for the study. Data will be prospectively recorded according to the data collection form. The use of the DAT clip will be performed as medically indicated and consistent with the indications for endoscopic clipping (e.g., management of bleeding, treatment of fistulas, perforations, tissue approximation). The investigators on this project will also oversee the medical care of all patients that will participate in the study. Therefore, follow-up will be carried out as medically indicated and no clinical visits will be needed specifically for the purpose of this study. | Device | – |
Primary outcome
Complete closure rate.
Time frame: 12 months
Cases in which complete tissue approximation is achieved with the use of the DAT clip- no substantial gaps are visible in the closure line.
3 secondary outcomes
Rate of Achievement of intended targeted therapy.
Time frame: 12 months
Procedural time.
Time frame: 12 months
Adverse Events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 16650531Technology Assessment Committee; Chuttani R, Barkun A, Carpenter S, Chotiprasidhi P, Ginsberg GG, Hussain N, Liu J, Silverman W, Taitelbaum G, Petersen B. Endoscopic clip application devices. Gastrointest Endosc. 2006 May;63(6):746-50. doi: 10.1016/j.gie.2006.02.042. No abstract available.
- Background: PubMed 30056253Wang TJ, Aihara H, Thompson AC, Schulman AR, Thompson CC, Ryou M. Choosing the right through-the-scope clip: a rigorous comparison of rotatability, whip, open/close precision, and closure strength (with videos). Gastrointest Endosc. 2019 Jan;89(1):77-86.e1. doi: 10.1016/j.gie.2018.07.025. Epub 2018 Jul 27.
- Background: PubMed 33965383Zhang Q, Jin HY, Shen ZH, Ma XJ, Li CQ, Tang Z, Bai Y, Wang Z. Novel through-the-scope twin clip for the closure of GI wounds: the first experimental survival study in pigs (with videos). Gastrointest Endosc. 2021 Oct;94(4):850-858.e2. doi: 10.1016/j.gie.2021.04.027. Epub 2021 May 7.
- Derived from this study: PubMed 37481003Mohammed A, Gonzaga ER, Hasan MK, Saeed A, Friedland S, Bilal M, Sharma N, Jawaid S, Othman M, Khalaf MA, Hwang JH, Viana A, Singh S, Hayat M, Cosgrove ND, Jain D, Arain MA, Kadkhodayan KS, Yang D. Low delayed bleeding and high complete closure rate of mucosal defects with the novel through-the-scope dual-action tissue clip after endoscopic resection of large nonpedunculated colorectal lesions (with video). Gastrointest Endosc. 2024 Jan;99(1):83-90.e1. doi: 10.1016/j.gie.2023.07.025. Epub 2023 Jul 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dennis Yang, MD principal investigator
AdventHealth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GI Bleeding and Perforation Colon, run by AdventHealth at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis Yang, MD (407-303-2570, Dennis.Yang.MD@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete closure rate. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05852457, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.